The purpose of this study is to determine if oral dronabinol prior to sleep can improve CPAP adherence and sleep quality in humans. We also seek to determine if combination therapy of CPAP and pre-sleep dronabinol is associated with improved BP regulation. We will also explore BP regulatory mechanisms and whether these are impacted differently between traditional CPAP therapy and combination CPAP/dronabinol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
10 mg dose of Dronabinol daily for 6 weeks
10 mg dose of Placebo daily for 6 weeks
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Number of times subjects complete CPAP therapy
CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night
Time frame: Baseline
Apnea-hypopnea index (AHI)
Apnea-hypopnea index (AHI) an index used to describe the number of apneas experienced during sleep. It is calculated by (Number of hours of sleep/Number of Apneas or hypopneas). This value will then be graded on a scale from Normal (\<5) to Severe (\>30).
Time frame: Day 15, Day 29, and Day 42
International Physical Activity Questionnaire
International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality
Time frame: Baseline and Day 42
24-hour blood pressure
Blood pressure will be monitored for 24 hours and reported as mm/Hg
Time frame: Baseline and Day 42
Blood Pressure
Blood Pressure will be reported as mm/Hg
Time frame: Baseline, Day 22, and Day 42
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