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Corticosteroid

Dronabinol for Sleep Apnea (DROSA Trial)

Phase 1 & 2
Waitlist Available
Led By Bharati Prasad, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults 18 to 65 years of age
Be older than 18 years old
Must not have
History of upper airway surgery for OSA (except adenotonsillectomy)
Arterial oxygen saturation < 75% for > 5% sleep time on pretreatment polysomnography
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial will test if Dronabinol can help with obstructive sleep apnea. Participants will take Dronabinol by mouth for two weeks and undergo sleep studies before and after to see if

Who is the study for?
This trial is for individuals with obstructive sleep apnea (OSA). Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis of OSA and be in stable health to participate.
What is being tested?
The trial is testing the effectiveness of Dronabinol, an oral medication, in treating OSA. It's an open-label study where all participants will receive the drug for two weeks with sleep studies before and after treatment to assess changes.
What are the potential side effects?
Potential side effects of Dronabinol can include dizziness, drowsiness, dry mouth, euphoria, confusion or disorientation. However, specific side effects related to this trial have not been listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery for sleep apnea, not including adenotonsillectomy.
Select...
My oxygen levels drop below 75% when I sleep.
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My BMI is over 45 kg/m2.
Select...
I use a CPAP machine for sleep apnea more than 4 hours a night.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apnea hypopnea index (AHI)
Secondary study objectives
T<90
Other study objectives
24-hour mean arterial blood pressure (BP)
Epworth Sleepiness Scale (ESS)
Functional Outcomes of Sleep Questionnaire (FOSQ)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single groupExperimental Treatment1 Intervention
Open label Dronabinol treatment for two weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
2003
Completed Phase 4
~2080

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoOTHER
639 Previous Clinical Trials
1,569,016 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,684 Total Patients Enrolled
Bharati Prasad, MDPrincipal InvestigatorJesse Brown VA Medical Center, Chicago, IL
2 Previous Clinical Trials
295 Total Patients Enrolled
~80 spots leftby Dec 2026
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