Obstructive Sleep Apnea
Conditions
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).
Interventions
DRUGDexmedetomidine
DRUGPlacebo
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | 8 hour sleep study | The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed