Sedative Effects in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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).

Official Title
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Dexmedetomidine for Sedation in Individuals With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine infusion<br>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 | Drug: Dexmedetomidine<br> <br> * Other names: Precedex;|
| Placebo Comparator: Placebo<br>Normal saline infusions will be administered over 4 hours at rates mimicking the DEX infusion rate | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index | The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index | 8 hour sleep study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During 8 hour sleep study |