INTERVENTIONALNOT YET RECRUITINGNCT07570953
Effects Of Nocturnal Dronabinol Use On Obstructive Sleep Apnea Treatment And Physiological Outcomes
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-08-13
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE2, PHASE3
- Enrollment
- 72 (ESTIMATED)
- Start date
- 2026-09
- Sponsor
- Mayo Clinic
- Design
- RANDOMIZED · PARALLEL · TREATMENT
- Locations
- 1
- Results record
- Not present in registry snapshot
Obstructive Sleep Apnea
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Conditions
No published condition report matched.
Cannabinoids and active compounds
Interventions
What was registered
DRUGDronabinol
10 mg dose of Dronabinol daily for 6 weeks
DRUGPlacebo
10 mg dose of Placebo daily for 6 weeks
Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 21 Years
- Maximum age
- 70 Years
- Healthy volunteers
- Not accepted
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
primary outcomes
primary measures
Number of times subjects complete CPAP therapy
Time frame: Baseline
CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night
Apnea-hypopnea index (AHI)
Time frame: 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
Time frame: Baseline and Day 42
International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality
secondary outcomes
secondary measures
24-hour blood pressure
Time frame: Baseline and Day 42
Blood pressure will be monitored for 24 hours and reported as mm/Hg
Blood Pressure
Time frame: Baseline, Day 22, and Day 42
Blood Pressure will be reported as mm/Hg
Publications
Locally readable linked articles
No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- 9249b5f0-88ec-4b70-8396-0ef1e6731609
- Retrieved
- 11/09/2026, 14:14:24
- SHA-256
- ae71213f334594b231435f257f96607b71465f662a1d1bcbc677ae5d6b3680d0