Obstructive Sleep Apnea Treatment in Serious Mental Illness
Part of paid clinical trials in La Jolla, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT05457127
- Status
- Not Yet Recruiting
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Conditions
- Bipolar Disorder
- Obstructive Sleep Apnea of Adult
- Schizoaffective Disorder
- Schizophrenia
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 70 Years
- Healthy Volunteers
- Accepted
Interventions
- Automatic Positive Airway Pressure (APAP) — DEVICEIf eligible, participants will be given a clinical Automatic Positive Airway Pressure (APAP) device for up to 3 months, while they are waiting for their clinical evaluation from a sleep physician. The APAP device will we will be using is the ResMed Airsense 11 Autoset. APAP is a smart positive airway pressure (PAP) device, where the pressure changes as needed to provide optimal pressure to splint the upper airway. Dr. Lee and Dr. Schmickl will oversee management of the device. During the first month of APAP use, individuals will participate in weekly phone calls or in-person visits to ensure optimal adherence and troubleshoot any issues (improper mask fitting, discomfort, etc) that may arise.
Study Details
Serious mental illnesses (SMI) like schizophrenia and bipolar disorder are two of the most disabling and costly chronic illnesses worldwide. A high proportion of adults with schizophrenia and bipolar disorder have sleep disorders, like obstructive sleep apnea (OSA), but tend to be underdiagnosed and undertreated compared to the general population. This study aims to examine feasibility, acceptance, and impact of OSA treatment and how it affects cognitive function in people with SMI.
Key Dates
- Start date
- Jan 1, 2025
- Status verified
- Jul 2024
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Automatic Positive Airway Pressure (APAP) device
Primary Outcome Measure
Acceptance of PAP trial [ Time Frame: 3 months ]
Central Contacts
- Ellen Lee, M.D.858-314-8126
- Stephanie Ibrahim(858) 255-0721
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSD | La Jolla | California | 92037 |
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