Sedative Effects in Obstructive Sleep Apnea

Phase 2

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Placebo; Drug: Dexmedetomidine

• Registration Number: NCT01733043
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-26
• Status Verified: 2015-03
• Study Start: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-04
• Primary Completion: 2015-05
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline infusions will be administered over 4 hours at rates mimicking the DEX infusion rate
Dexmedetomidine infusion	Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	8 hour sleep study	The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index

Secondary Outcome Measures

Name	Time	Method
Sleep Architecture	During 8 hour sleep study	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