DRonabinol Treatment of OSA
NCT Number: NCT06477952
Acronym: DROSA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Obstructive Sleep Apnea
Interventions: DRUG: Dronabinol
Sponsor: VA Office of Research and Development
Collaborators: University of Illinois at Chicago
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-12-31
Locations: Jesse Brown VA Medical Center, Chicago, IL, Chicago, Illinois, 60612, United States

Summary:
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.

Primary Outcome Measures: Apnea hypopnea index (AHI), The change in AHI after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms., 2 weeks
Secondary Outcome Measures: T<90, The change in time below 90% oxygen saturation (T\<90) after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms., 2 weeks
Other Outcome Measures: Psychomotor Vigilance Test (PVT), The change in Lapses on Psychomotor Vigilance Test (PVT) after two weeks of Dronabinol treatment will be determined from before and after treatment PVT using a 10 minute protocol., 2 weeks|24-hour mean arterial blood pressure (BP), The change in 24- hour mean arterial blood pressure after two weeks of Dronabinol treatment will be determined from before and after treatment 24-hiur ambulatory BP recording., 2 weeks|Sleep Efficiency, The change in sleep efficiency after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms., 2 weeks|REM sleep, The change in REM sleep after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms., 2 weeks|Slow wave sleep, The change in slow wave sleep after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms., 2 weeks|Treatment Satisfaction Questionnaire for Medication (TSQM), Patient reported treatment satisfaction. TSQM scores have a range of 0 to 100, with higher scores indicating higher satisfaction., 2 weeks|Epworth Sleepiness Scale (ESS), The change in Epworth Sleepiness Scale (ESS) will be measured after two weeks of Dronabinol treatment.

ESS scores have a range of 0 to 24, with higher scores indicating greater sleepiness., 2 weeks|Functional Outcomes of Sleep Questionnaire (FOSQ), The change in Functional Outcomes of Sleep Questionnaire (FOSQ) will be measured after two weeks of Dronabinol treatment.

FOSQ score ranges from 5-20, with higher scores indicating better functional status., 2 weeks|Pittsburgh Sleep Quality Index (PSQI), The change in Pittsburgh Sleep Quality Index (PSQI) will be measured after two weeks of Dronabinol treatment.

The PSQI score ranges from 0 to 21. Higher scores indicate poorer sleep quality., 2 weeks|Insomnia Severity Index (ISI), The change in Insomnia Severity Index (ISI) will be measured after two weeks of Dronabinol treatment.

ISI ranges from 0 to 28, with higher scores indicating greater sleep disturbance., 2 weeks|Post-Traumatic Stress Disorder; PTSD checklist (PCL-5), The change in Post-Traumatic Stress Disorder; PTSD checklist (PCL-5) will be measured after two weeks of Dronabinol treatment.

PCL-5 scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity., 2 weeks