Dronabinol for obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 1/2 trial gives oral dronabinol daily for two weeks to Veterans with obstructive sleep apnea and measures apnea-hypopnea index before and after treatment using overnight polysomnography. Up to 120 Veterans will be screened so that about 45 can complete the two-week treatment and paired sleep studies. Clinical data (age, sex, BMI, comorbidities) and pretreatment polysomnographic endotypes (sleep architecture, respiratory disturbance, loop gain, arousal threshold, upper airway collapsibility and compensation) will be used to develop a prediction model for AHI reduction with dronabinol. The prediction model is intended to guide a future randomized clinical trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\. AHI 15-50 per hour on pre-treatment polysomnography

Exclusion Criteria:

1. Positive Airway Pressure (PAP) treatment of obstructive sleep apnea (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 adenotonsillectomy)
4. Central or mixed apneas \>25% of respiratory events on diagnostic polysomnography
5. Arterial oxygen saturation \< 75% for \> 5% sleep time on pretreatment polysomnography
6. Body mass index \> 45 kilograms per square meter (kg/m2)
7. If post-bariatric surgery, weight must be stable ±5% (per electronic medical records) for at least 6 months before the first dose of the study drug
8. Active enrollment in a weight loss program
9. Shiftwork within 3 months of enrollment
10. High-risk occupation: commercial driver and pilot
11. Motor vehicle accident or near-miss incident within 1 year of enrollment
12. Current drug or habitual alcohol use or positive urine drug screen
13. Comorbid medical and psychiatric disorders:

    1. Primary sleep disorders: e.g., narcolepsy, restless legs syndrome
    2. Uncontrolled mood disorder or a diagnosis of schizophrenia
    3. Initiation of new antidepressant or antipsychotic medication within 3 months
    4. Identified as high-risk for suicide in electronic health records
    5. Uncontrolled medical disorders (coronary heart disease, arrhythmia, congestive heart failure, chronic obstructive pulmonary disease, chronic hypoxemic or hypercapnic respiratory failure, stroke within 6 months of enrollment, chronic liver or kidney disease, autoimmune disorders)
14. Use of sedative-hypnotic medications within 30 days of enrollment
15. Complete blood count or liver function test values more than 1.5 times the upper limit of normal
16. Pregnancy
17. Allergy to cannabinoids or sesame oil
18. Average weekly alcohol consumption of more than 10 servings
19. Participation in other investigational protocols within 30 days of enrollment

Where it's running

• Jesse Brown VA Medical Center, Chicago, IL
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Bharati Prasad, MD — Jesse Brown VA Medical Center, Chicago, IL
• Study coordinator: Bharati Prasad, MD
• Email: bharati.prasad@va.gov
• Phone: (312) 996-8433

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CES-EES score and a wearable ring for diagnosing obstructive sleep apnea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.