<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/NCT01733043</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00033021</org_study_id>
    <nct_id>NCT01733043</nct_id>
  </id_info>
  <brief_title>Sedative Effects in Obstructive Sleep Apnea</brief_title>
  <official_title>Dexmedetomidine for Sedation in Individuals With Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the effect of dexmedetomidine infusion on the&#xD;
      Apnea / Hypopnea Index (AHI) of individuals with previously documented obstructive sleep&#xD;
      apnea. We hypothesize that dexmedetomidine infusion may reduce the AHI in patients with&#xD;
      obstructive sleep apnea (OSA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Failure to secure funding&#xD;
  </why_stopped>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea Hypopnea Index</measure>
    <time_frame>8 hour sleep study</time_frame>
    <description>The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Architecture</measure>
    <time_frame>During 8 hour sleep study</time_frame>
    <description>Additional measures of sleep architecture will be made: sleep onset latency, duration of time spent in rapid eye movement (REM) and non-rapid eye movement (NREM) sleep, sleep efficiency, and number of arousals</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexmedetomidine 0.5 mcg/kg loading dose administered over 20 minutes, followed by 0.6 mcg/kg/hr infusion for 1 hour and 40 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline infusions will be administered over 4 hours at rates mimicking the DEX infusion rate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <arm_group_label>Dexmedetomidine infusion</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All individuals who have previously undergone diagnostic polysomnography in the Sleep&#xD;
             Lab which documented significant OSA, and who have not undergone any changes that are&#xD;
             likely to alter the severity of their condition since the time of their diagnostic&#xD;
             sleep study (loss of weight; surgical therapy for OSA; removal of tonsils;&#xD;
             discontinuation of medications likely to affect arousal or respiratory function, etc.)&#xD;
             are eligible to participate. Subjects will be identified as they complete outpatient&#xD;
             sleep studies or from records of previous sleep studies performed in the Duke Sleep&#xD;
             Laboratory. After obtaining informed consent, subjects will be screened by history and&#xD;
             physical examination, 12-lead electrocardiogram, and comprehensive metabolic profile.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria will include a history of illicit drug or alcohol dependence,&#xD;
             impaired hepatic (aspartate aminotransferase or alanine aminotransferase &gt; 2x upper&#xD;
             limit of normal range) or renal function (receiving dialysis or serum creatinine &gt; 1.5&#xD;
             mg/dL), high-grade (&gt; 1st degree) heart block, or known allergy to dexmedetomidine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Colin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>March 2, 2015</last_update_submitted>
  <last_update_submitted_qc>March 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01733043
org study id: Pro00033021
nct id: NCT01733043
lead sponsor: 
has dmc: No
The objective of this study is to determine the effect of dexmedetomidine infusion on the
      Apnea / Hypopnea Index (AHI) of individuals with previously documented obstructive sleep
      apnea. We hypothesize that dexmedetomidine infusion may reduce the AHI in patients with
      obstructive sleep apnea (OSA).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Apnea Hypopnea Index
time frame: 8 hour sleep study
description: The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index
measure: Sleep Architecture
time frame: During 8 hour sleep study
description: Additional measures of sleep architecture will be made: sleep onset latency, duration of time spent in rapid eye movement (REM) and non-rapid eye movement (NREM) sleep, sleep efficiency, and number of arousals
arm group label: Dexmedetomidine infusion
arm group type: Experimental
description: Dexmedetomidine 0.5 mcg/kg loading dose administered over 20 minutes, followed by 0.6 mcg/kg/hr infusion for 1 hour and 40 minutes
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal saline infusions will be administered over 4 hours at rates mimicking the DEX infusion rate
intervention type: Drug
intervention name: Dexmedetomidine
arm group label: Dexmedetomidine infusion
other name: Precedex
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Colin, MD
role: Principal Investigator
affiliation: Duke University
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Dexmedetomidine