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Withdrawn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
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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.
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
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
Learn more about this trial
Sedative Effects in Obstructive Sleep Apnea
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