RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Dronabinol for Obstructive Sleep Apnea

This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks.

Official registry: https://clinicaltrials.gov/study/NCT06477952 · VA Office of Research and Development · enrollment listed as 120

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Dronabinol. The registry lists allocation as na. This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA).

They plan to enroll about 120 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial

Interventions: Dronabinol

Primary outcome (registry wording): Apnea Hypopnea Index (AHI)

Who it is for (from inclusion criteria)

Ages any to 65 Years
1\. AHI 15-50 per hour on pre-treatment polysomnography

Who the registry excludes

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
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
History of upper airway surgery for OSA (except adenotonsillectomy)
Central or mixed apneas \>25% of respiratory events on diagnostic polysomnography
Arterial oxygen saturation \< 75% for \> 5% sleep time on pretreatment polysomnography
Body mass index \> 45 kilograms per square meter (kg/m2)
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

Public study contact (from the registry)

Bharati Prasad, MD

(312) 996-8433

bharati.prasad@va.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois (recruiting)

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FAQ about this NCT record

Is NCT06477952 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06477952?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06477952?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary