<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02202811</url>
  </required_header>
  <id_info>
    <org_study_id>OSA 00010101</org_study_id>
    <nct_id>NCT02202811</nct_id>
  </id_info>
  <brief_title>Circadian Rhythms and Cardiovascular Risk</brief_title>
  <official_title>Circadian Rhythms and Cardiovascular Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to understand how behaviors and the effects of the body's&#xD;
      internal clock (called the circadian pacemaker) affect the control of the heart and blood&#xD;
      pressure.&#xD;
&#xD;
      People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian&#xD;
      amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian&#xD;
      phase in some of the same key indices of CV risk. The investigators hypothesize that such&#xD;
      changes, taken together, may explain the different timing of heart attack and sudden cardiac&#xD;
      death in OSA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">March 9, 2020</completion_date>
  <primary_completion_date type="Actual">March 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP)</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of systolic and diastolic BP during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of blood pressure (BP)</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of systolic and diastolic BP during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of plasma cortisol concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma cortisol concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of plasma cortisol concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma cortisol concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of heart rate</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of heart rate during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of heart rate</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of heart rate during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of heart rate reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of heart rate reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of cardiac vagal tone during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of cardiac vagal tone</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of cardiac vagal tone during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma tissue plasminogen activator inhibitor (tPA) concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma tPA concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma tPA concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma tPA concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of vascular endothelial function during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of vascular endothelial function</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of vascular endothelial function during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma plasminogen activator inhibitor 1 (PAI-1) concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma PAI-1 concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma PAI-1 concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma MDA concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma MDA concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma MDA concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma MDA reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma 8-isoprostane concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane concentration</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma 8-isoprostane concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to exercise</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to change in posture</measure>
    <time_frame>Over 5 days</time_frame>
    <description>Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Obstructive Sleep Apnea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Forced Desynchrony, OSA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Forced Desynchrony, Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Forced Desynchrony</intervention_name>
    <description>all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Obstructive Sleep Apnea</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  BMI less than 40&#xD;
&#xD;
          -  Moderate to severe OSA (AHI)&gt;15&#xD;
&#xD;
          -  No current or previous pharmacological treatment for hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven A Shea, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>April 14, 2020</last_update_submitted>
  <last_update_submitted_qc>April 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Steven A. Shea</investigator_full_name>
    <investigator_title>Dr. Steven A. Shea, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02202811
org study id: OSA 00010101
nct id: NCT02202811
lead sponsor: 
has dmc: No
The purpose of this study is to understand how behaviors and the effects of the body's
      internal clock (called the circadian pacemaker) affect the control of the heart and blood
      pressure.

      People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian
      amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian
      phase in some of the same key indices of CV risk. The investigators hypothesize that such
      changes, taken together, may explain the different timing of heart attack and sudden cardiac
      death in OSA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP)
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of systolic and diastolic BP during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of blood pressure (BP)
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of systolic and diastolic BP during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of plasma cortisol concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma cortisol concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of plasma cortisol concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma cortisol concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of heart rate
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of heart rate during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of heart rate
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of heart rate during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of heart rate reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of heart rate reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of cardiac vagal tone during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of cardiac vagal tone
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of cardiac vagal tone during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma tissue plasminogen activator inhibitor (tPA) concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma tPA concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma tPA concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma tPA concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of vascular endothelial function during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of vascular endothelial function
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of vascular endothelial function during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma plasminogen activator inhibitor 1 (PAI-1) concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma PAI-1 concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma PAI-1 concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma MDA concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma MDA concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma MDA concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma MDA reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma 8-isoprostane concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane concentration
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma 8-isoprostane concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to exercise
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
measure: Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to change in posture
time frame: Over 5 days
description: Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
arm group label: Obstructive Sleep Apnea
arm group type: Experimental
description: Forced Desynchrony, OSA
arm group label: Control
arm group type: Placebo Comparator
description: Forced Desynchrony, Control
intervention type: Behavioral
intervention name: Forced Desynchrony
description: all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.
arm group label: Control
arm group label: Obstructive Sleep Apnea
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven A Shea, PhD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Steven A. Shea
investigator title: Dr. Steven A. Shea, PhD
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided