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Sedative Effects in Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All individuals who have previously undergone diagnostic polysomnography in the Sleep Lab which documented significant OSA, and who have not undergone any changes that are likely to alter the severity of their condition since the time of their diagnostic sleep study (loss of weight; surgical therapy for OSA; removal of tonsils; discontinuation of medications likely to affect arousal or respiratory function, etc.) are eligible to participate. Subjects will be identified as they complete outpatient sleep studies or from records of previous sleep studies performed in the Duke Sleep Laboratory. After obtaining informed consent, subjects will be screened by history and physical examination, 12-lead electrocardiogram, and comprehensive metabolic profile.

Exclusion Criteria:

  • Exclusion criteria will include a history of illicit drug or alcohol dependence, impaired hepatic (aspartate aminotransferase or alanine aminotransferase > 2x upper limit of normal range) or renal function (receiving dialysis or serum creatinine > 1.5 mg/dL), high-grade (> 1st degree) heart block, or known allergy to dexmedetomidine.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Dexmedetomidine infusion

    Placebo

    Arm 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

    Normal saline infusions will be administered over 4 hours at rates mimicking the DEX infusion rate

    Outcomes

    Primary Outcome Measures

    Apnea Hypopnea Index
    The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index

    Secondary Outcome Measures

    Sleep Architecture
    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

    Full Information

    First Posted
    November 20, 2012
    Last Updated
    March 2, 2015
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01733043
    Brief Title
    Sedative Effects in Obstructive Sleep Apnea
    Official Title
    Dexmedetomidine for Sedation in Individuals With Obstructive Sleep Apnea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Failure to secure funding
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    May 2015 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexmedetomidine infusion
    Arm Type
    Experimental
    Arm 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 Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Normal saline infusions will be administered over 4 hours at rates mimicking the DEX infusion rate
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    Precedex
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Apnea Hypopnea Index
    Description
    The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index
    Time Frame
    8 hour sleep study
    Secondary Outcome Measure Information:
    Title
    Sleep Architecture
    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
    Time Frame
    During 8 hour sleep study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All individuals who have previously undergone diagnostic polysomnography in the Sleep Lab which documented significant OSA, and who have not undergone any changes that are likely to alter the severity of their condition since the time of their diagnostic sleep study (loss of weight; surgical therapy for OSA; removal of tonsils; discontinuation of medications likely to affect arousal or respiratory function, etc.) are eligible to participate. Subjects will be identified as they complete outpatient sleep studies or from records of previous sleep studies performed in the Duke Sleep Laboratory. After obtaining informed consent, subjects will be screened by history and physical examination, 12-lead electrocardiogram, and comprehensive metabolic profile. Exclusion Criteria: Exclusion criteria will include a history of illicit drug or alcohol dependence, impaired hepatic (aspartate aminotransferase or alanine aminotransferase > 2x upper limit of normal range) or renal function (receiving dialysis or serum creatinine > 1.5 mg/dL), high-grade (> 1st degree) heart block, or known allergy to dexmedetomidine.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Colin, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Sedative Effects in Obstructive Sleep Apnea

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