RECRUITING

DRonabinol Treatment of OSA

Conditions

Obstructive Sleep Apnea OSA sleep apnea pharmacological treatment Drug treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-25

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06477952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults 18 to 65 years of age. 2. AHI 15-50 per hour on pre-treatment polysomnography.	1. Positive Airway Pressure (PAP) treatment of 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 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.

Inclusion Criteria

Exclusion Criteria

1. Adults 18 to 65 years of age.
2. AHI 15-50 per hour on pre-treatment polysomnography.

1. Positive Airway Pressure (PAP) treatment of 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 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.

Contacts and Locations

Study Contact

Bharati Prasad, MD

CONTACT

(312) 996-8433

bharati.prasad@va.gov

Karen M Lenehan

CONTACT

(312) 569-6343

Karen.Lenehan@va.gov

Principal Investigator

Bharati Prasad, MD

PRINCIPAL_INVESTIGATOR

Jesse Brown VA Medical Center, Chicago, IL

Study Locations (Sites)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Bharati Prasad, MD, PRINCIPAL_INVESTIGATOR, Jesse Brown VA Medical Center, Chicago, IL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-25

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-08-25

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

OSA
sleep apnea
pharmacological treatment
Drug treatment

Additional Relevant MeSH Terms

Obstructive Sleep Apnea