Overview

Sedative Effects in Obstructive Sleep Apnea

Status:
Withdrawn

Trial end date:
2015-11-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Duke University

Treatments:

Dexmedetomidine

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.