DRonabinol Treatment of OSA
A legfontosabb adatok
- Hol
- Chicago (Egyesült Államok)A helyszín megnézése
- Fázis
- 1/2. fázis
Helyszínek itt: Egyesült Államok
- Jesse Brown VA Medical Center, Chicago, ILChicago, Egyesült ÁllamokContact: Karen M LenehanRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- VA Office of Research and Development
- Azonosító
- NCT06477952
- A regiszteradat frissítve
- 2026. november 5.
- Eredeti leírás
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. Sleep studies will be conducted before and after treatment to measure OSA severity.A teljes eredeti leírásKevesebb
Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial
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. Sleep studies will be conducted before and after treatment to measure OSA severity.
Bevonási feltételek: AHI 15-50 per hour on pre-treatment polysomnography.
Kizáró feltételek: 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; 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; Current drug or habitual alcohol use or positive urine drug screen; Use of sedative-hypnotic medications within 30 days of enrollment; History of upper airway surgery for OSA (except adenotonsillectomy); Comorbid medical and psychiatric disorders:; Primary sleep disorders: e.g., narcolepsy, restless legs syndrome; Uncontrolled mood disorder or a diagnosis of schizophrenia; Initiation of new antidepressant or antipsychotic medication within 3 months; Identified as high-risk for suicide in electronic health records; 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); Allergy to cannabinoids or sesame oil; Complete blood count or liver function test values more than 1.5 times the upper limit of normal; 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; 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); Active enrollment in a weight loss program; Shiftwork within 3 months of enrollment; High-risk occupation: commercial driver and pilot; Motor vehicle accident or near-miss incident within 1 year of enrollment; Pregnancy; Average weekly alcohol consumption of more than 10 servings; Participation in other investigational protocols within 30 days of enrollment.