Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477952
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
DRonabinol Treatment of OSA
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Targeted Treatment of Obstructive Sleep Apnea With Dronabinol Proof of Concept and Phase II Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DROSA
Brief 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
Detailed Description:
Obstructive sleep apnea OSA is a serious respiratory disorder that involves repetitive cessation of breathing during sleep It is estimated that 15-20 million people in the United States suffer from OSAS which has been linked to increased risk for hypertension heart failure depression and diabetes The current standard of care for OSA positive airway pressure PAP involves a mechanical device with low patient tolerance and adherence Upper airway surgical approaches are also an option but are invasive and often unsuccessful Effective drug treatments for OSA remain to be identified
This study will enroll up to 120 Veterans so that 45 Veterans may complete the two-week open-label Dronabinol treatment trials The results of the study will be used to develop a prediction model for OSA severity reduction after 2-week Dronabinol treatment vs pretreatment AHI Participants clinical age sex body mass index comorbidity and pretreatment polysomnographic characteristics sleep architecture respiratory disturbance and endotypes loop-gain arousal threshold upper airway collapsibility and compensation will be used to develop a prediction model for improvement of OSA with Dronabinol treatment This prediction model will be used for a randomized clinical trial after the completion of this trial
This study will enroll up to 120 Veterans so that 45 Veterans may complete the two-week open-label Dronabinol treatment trials The results of the study will be used to develop a prediction model for OSA severity reduction after 2-week Dronabinol treatment vs pretreatment AHI Participants clinical age sex body mass index comorbidity and pretreatment polysomnographic characteristics sleep architecture respiratory disturbance and endotypes loop-gain arousal threshold upper airway collapsibility and compensation will be used to develop a prediction model for improvement of OSA with Dronabinol treatment This prediction model will be used for a randomized clinical trial after the completion of this trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None