Endotype-Targeted Therapy to Rescue OSA Patients Struggling with CPAP Adherence (TOP-CPAP): a Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

More than 10% of the US population have obstructive sleep apnea (OSA). Standard of care is therapy with CPAP (continuous positive airway pressure) which virtually eliminates OSA. However, most patients use CPAP only for part of the night (4-5hours) and about 50% patients discontinue CPAP long-term. Alternative therapies are limited, thus many OSA patients remain at risk of OSA sequelae (e.g. sleepiness, memory issues, high blood pressure, etc.). Importantly, different patients get OSA for different reasons, and recent data show that some of the underlying causes of OSA (endotypes) such as having a low arousal threshold (i.e. waking up easily) are associated with lower CPAP adherence. Using a randomized controlled trial design, this will be the first study using a targeted intervention to manipulate the underlying OSA causes (i.e., giving a safe hypnotic to patients with OSA to increase the arousal threshold) to test the hypothesis that endotype-targeted therapy increases CPAP-adherence in patients who have low but continued CPAP usage. Ultimately, this strategy may improve the care and outcomes of millions of undertreated OSA patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
View:

• Ages 21-65 years old

• Body Mass Index \<32 kg/m\^2

• Physician diagnosis of OSA (AHI ≥ 10) based on a clinical sleep study within the past 2 years (subjects who report a history of sleep apnea but do not have a sleep study report from the past 2 years available will be offered an overnight home sleep apnea test to verify OSA diagnosis)

• AHI\>5/h on the overnight research sleep study #1

• Subject had the opportunity to use CPAP for at least 1 month

• Continuous positive airway pressure (CPAP) data can be queried remotely and shows usage 0.5-4h/night (based on most recent 30 day period)

• Interest to continue trying CPAP

Locations
United States
California
UC San Diego; Altman Clinical and Translational Research Institute Building
RECRUITING
La Jolla
Contact Information
Primary
Pamela DeYoung, RPSGT
sleepresearch@health.ucsd.edu
858 246 2183
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 50
Treatments
Experimental: Eszopiclone
Subjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
Placebo_comparator: Placebo
Subjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
Related Therapeutic Areas
Sponsors
Collaborators: American Academy of Sleep Medicine
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov