Trial Summary
What is the purpose of this trial?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 suboptimal adherence, defined by the Center of Medicare and Medicaid criteria (\<70 % usage and \<4 hours of average daily PAP usage) will be identified. The purpose of this research is to examine the impact of the sleep apnea management (SAM) grouped based-intervention on positive airway pressure adherence and patient report outcomes questionnaires (quality of life, daytime sleepiness and depressive symptoms) and PAP barrier questionnaire compared to a patient group managed by regular non-sleep prescribing provider.
Eligibility Criteria
Adults over 18 with moderate-to-severe obstructive sleep apnea who are new to using a PAP machine and aren't using it enough (<70% usage, <4 hours daily). They must be under the care of non-sleep specialists and able to attend the SAM clinic. Pregnant women, those on oxygen therapy, or unable to consent are excluded.Inclusion Criteria
You have had a new PAP test within the past month.
You don't use your PAP machine enough, less than 70% of the time and less than 4 hours a night on average.
I am 18 years old or older.
+2 more
Exclusion Criteria
Pregnant women
I have central sleep apnea or Cheyne-Stokes breathing.
I cannot go to the SAM clinic.
+2 more
Participant Groups
The trial is testing a group intervention called SAM Clinic Intervention for people with sleep apnea who struggle with their PAP machine use. It aims to see if this support improves how often they use their machines and enhances quality of life, alertness during the day, and mood compared to usual care.
2Treatment groups
Experimental Treatment
Active Control
Group I: SAM Clinic InterventionExperimental Treatment1 Intervention
Participants will attend a sleep apnea management group based intervention to improve PAP adherence.
Group II: Usual care with non-sleep providerActive Control1 Intervention
Participant will continue the follow up for sleep apnea with the non-sleep provider
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic FoundationCleveland, OH
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
ResMedIndustry Sponsor