Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
DRUGDronabinol
10 mg dose of Dronabinol daily for 6 weeks
DRUGPlacebo
10 mg dose of Placebo daily for 6 weeks
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 21 - 70 years of age * Biological male or female * AHI between 15 - 50 events/hour * Current or new OSA diagnosis * Established or new (within 1 month) CPAP therapy
Exclusion criteria
* BMI \> 35 kg/m2 * Diagnosed psychiatric disorders * Hypotension * History of seizures * History of substance abuse or recreational drug use or positive urine drug screen * History of uncontrolled disease including: * Cardiovascular * Pulmonary * Gastrointestinal * Pancreatic * Hepatic * Renal * Hematological * Endocrine (including Type I Diabetes) * Neurological * Urological * Pregnant or breastfeeding * Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs * Prescribed CYP2C9 and/or CYP3A4 inhibitors * Severe OSA that in the investigator's judgment should only begin CPAP treatment * Prior upper airway surgery for snoring or OSA as an adult * Significant defect in nasal patency due to anatomical abnormality or uncontrolled rhinitis * Bariatric surgery within 2 years * Medically managed weight-loss program within 6 months * Noninvasive treatment for OSA within 1 month (self-report) * History of shift work or rotating shifts within 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of times subjects complete CPAP therapy | Baseline | CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night |
| Apnea-hypopnea index (AHI) | Day 15, Day 29, and Day 42 | 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). |
| International Physical Activity Questionnaire | Baseline and Day 42 | International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour blood pressure | Baseline and Day 42 | Blood pressure will be monitored for 24 hours and reported as mm/Hg |
| Blood Pressure | Baseline, Day 22, and Day 42 | Blood Pressure will be reported as mm/Hg |
Countries
United States
Contacts
CONTACTChieko Allgauer
PRINCIPAL_INVESTIGATORVirend Somers, M.D., Ph.D.
Mayo Clinic
Outcome results
None listed