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

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Automatic Positive Airway Pressure (APAP) — DEVICE
    If 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

Locations (1)

FacilityCityStateZIPSite coordinators
UCSDLa JollaCalifornia92037
Stephanie Ibrahim
858-255-0721

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