Status:
COMPLETED
SAMPAP Trial -Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure Adherence
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
ResMed
Conditions:
Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized controlled trial will evaluate people who have moderate-to-severe obstructive sleep apnea (OSA), and have been newly prescribed a Positive Airway Pressure (PAP) machine. Patients with ...
Detailed Description
The research involves collection of information from the medical record and PAP adherence collection website and completion of a survey at several time points. The survey asks questions about their ex...
Eligibility Criteria
Inclusion
- ≥18 years old
- Moderate to severe OSA (apnea hypopnea index (AHI)≥15 events/hr) on polysomnogram (PSG)
- Followed by non-sleep providers for OSA (mainly primary care providers)
- New PAP set up \< 1 month
- Sub-optimal PAP adherence by objective PAP adherence data (\<70 % usage and \<4 hours of average PAP usage)
Exclusion
- Central sleep apnea (\>50% apneas are central) and/or presence of Cheyne-Stokes breathing
- Pregnant women
- Patients on supplemental oxygen
- Patients not able to attend SAM clinic
- Inability to provide informed consent
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03835702
Start Date
April 1 2019
End Date
June 12 2025
Last Update
October 21 2025
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195