Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial
VA Office of Research and Development
Summary
This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks. Sleep studies will be conducted before and after treatment to measure OSA severity.
Description
Obstructive sleep apnea (OSA), is a serious respiratory disorder that involves repetitive cessation of breathing during sleep. It is estimated that 15-20 million people in the United States suffer from OSAS, which has been linked to increased risk for hypertension, heart failure, depression, and diabetes. The current standard of care for OSA, positive airway pressure (PAP), involves a mechanical device with low patient tolerance and adherence. Upper airway surgical approaches are also an option but are invasive and often unsuccessful. Effective drug treatments for OSA remain to be identified.…
Eligibility
- Age range
- Up to 65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults 18 to 65 years of age. 2. AHI 15-50 per hour on pre-treatment polysomnography. Exclusion Criteria: 1. Positive Airway Pressure (PAP) treatment of OSA: use \> 4 hours per day for 30% of days within 3 months of enrollment. PAP use will be determined from device download data. 2. Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use \> 4 hours per day for 30% of days within 3 months of enrollment. HNS use will be determined by device download and oral appliance use by self-report. 3. History of upper airway surgery for OSA (except adenoton…
Interventions
- DrugDronabinol
Open label Dronabinol treatment for two weeks.
Location
- Jesse Brown VA Medical Center, Chicago, ILChicago, Illinois