<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/NCT03043963</url>
  </required_header>
  <id_info>
    <org_study_id>2015P000243</org_study_id>
    <nct_id>NCT03043963</nct_id>
  </id_info>
  <brief_title>Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep</brief_title>
  <official_title>Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep Extension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to learn about the influence of two different behavioral&#xD;
      interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the&#xD;
      mechanisms involved. There is research evidence that healthy sleep promotes heart-health and&#xD;
      may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be&#xD;
      influenced by sex. This research will compare two interventions that are each designed to&#xD;
      improve sleep health, and will investigate sex differences in response. The project includes&#xD;
      3 in-hospital stays with biological measurements to evaluate the underlying mechanisms&#xD;
      associated with the effectiveness of two different blood pressure lowering behavioral&#xD;
      interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study involves home-based sleep-wake data collection before and during behavioral&#xD;
      intervention, and 3 overnight stays in the hospital. For each hospital stay participants will&#xD;
      be asked to arrive in the afternoon, and stay until the next evening. They will be provided&#xD;
      dinner on the first day and breakfast, lunch and dinner on the second day. If they are taking&#xD;
      any blood pressure medication they will continue to take it through the study. During the&#xD;
      in-hospital stays, blood pressure will be measured continuously using two small finger cuffs.&#xD;
      In order to monitor and record brain waves to determine sleep and wakefulness, small&#xD;
      gold-coated disks called electrodes will be placed on the head and body. Heart rate, blood&#xD;
      pressure and brain activity will be recorded for a little over 24 hours on each in-hospital&#xD;
      stay. Before as well as during the in-hospital stays questions will be asked about sleep&#xD;
      times, subjective sleepiness and other indices relating to well-being.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">September 21, 2022</completion_date>
  <primary_completion_date type="Actual">September 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in 24 hour blood pressure</measure>
    <time_frame>The primary outcome measure will be measured during 3 hospital visit periods of approximately 28 hours each. The primary outcome will be evaluated based on an 8 week behavioral intervention.</time_frame>
    <description>24h blood pressure (daily averaged).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lowering of sleep period blood pressure</measure>
    <time_frame>he primary outcome measure will be measured during 3 hospital visit periods ofThe secondary outcome will be evaluated based on an 8 week behavioral intervention.</time_frame>
    <description>Blood pressure during day wake period minus blood pressure at night during sleep period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Sleep Timing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention will include basic education concerning sleep hygiene and regularity of sleep timing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Extension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention will include basic education concerning sleep hygiene and an extension of the sleep period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Extension</intervention_name>
    <description>Lengthen the duration of sleep time.</description>
    <arm_group_label>Sleep Extension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Timing</intervention_name>
    <description>Regularize the timing of the sleep period.</description>
    <arm_group_label>Sleep Timing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pre-hypertension or stage one hypertension (BP ≥120/80 and &lt;160/100).&#xD;
&#xD;
          -  usual sleep period occurs at night&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant active or uncontrolled sleep disorders&#xD;
&#xD;
          -  shiftwork&#xD;
&#xD;
          -  current pregnancy&#xD;
&#xD;
          -  diabetic patients who are insulin dependent (or have HbA1c&gt;9.0%)&#xD;
&#xD;
          -  current use of hypnotics or clonidine&#xD;
&#xD;
          -  renal/electrolyte disorders and any other condition that the study screening physician&#xD;
             considers would significantly impede participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet M Mullington, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Janet M Mullington, PhD</investigator_full_name>
    <investigator_title>Professor of Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03043963
org study id: 2015P000243
nct id: NCT03043963
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to learn about the influence of two different behavioral
      interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the
      mechanisms involved. There is research evidence that healthy sleep promotes heart-health and
      may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be
      influenced by sex. This research will compare two interventions that are each designed to
      improve sleep health, and will investigate sex differences in response. The project includes
      3 in-hospital stays with biological measurements to evaluate the underlying mechanisms
      associated with the effectiveness of two different blood pressure lowering behavioral
      interventions.
The study involves home-based sleep-wake data collection before and during behavioral
      intervention, and 3 overnight stays in the hospital. For each hospital stay participants will
      be asked to arrive in the afternoon, and stay until the next evening. They will be provided
      dinner on the first day and breakfast, lunch and dinner on the second day. If they are taking
      any blood pressure medication they will continue to take it through the study. During the
      in-hospital stays, blood pressure will be measured continuously using two small finger cuffs.
      In order to monitor and record brain waves to determine sleep and wakefulness, small
      gold-coated disks called electrodes will be placed on the head and body. Heart rate, blood
      pressure and brain activity will be recorded for a little over 24 hours on each in-hospital
      stay. Before as well as during the in-hospital stays questions will be asked about sleep
      times, subjective sleepiness and other indices relating to well-being.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Reduction in 24 hour blood pressure
time frame: The primary outcome measure will be measured during 3 hospital visit periods of approximately 28 hours each. The primary outcome will be evaluated based on an 8 week behavioral intervention.
description: 24h blood pressure (daily averaged).
measure: Lowering of sleep period blood pressure
time frame: he primary outcome measure will be measured during 3 hospital visit periods ofThe secondary outcome will be evaluated based on an 8 week behavioral intervention.
description: Blood pressure during day wake period minus blood pressure at night during sleep period
arm group label: Sleep Timing
arm group type: Active Comparator
description: Intervention will include basic education concerning sleep hygiene and regularity of sleep timing
arm group label: Sleep Extension
arm group type: Experimental
description: Intervention will include basic education concerning sleep hygiene and an extension of the sleep period.
intervention type: Behavioral
intervention name: Sleep Extension
description: Lengthen the duration of sleep time.
arm group label: Sleep Extension
intervention type: Behavioral
intervention name: Sleep Timing
description: Regularize the timing of the sleep period.
arm group label: Sleep Timing
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janet M Mullington, PhD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Janet M Mullington, PhD
investigator title: Professor of Neurology
mesh term: Hypertension
sharing ipd: No