Who is eligible for clinical trial NCT05457127?

Participants must meet protocol criteria for Schizoaffective Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05457127 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-07-08

Obstructive Sleep Apnea Treatment in Serious Mental Illness (NCT05457127)

🟡 Not Yet Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of California, San Diego

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (7 items).

Location: UCSD — La Jolla, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Control participants:
lifetime absence of major psychiatric illness
40 to 70 years old
be at risk for or have a diagnosis of obstructive sleep apnea For participants with serious mental illness:
diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
must not be conservatized
40 - 70 years old
be at risk or have a diagnosis of obstructive sleep apnea.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
DSM-IV-TR diagnosis of active alcohol or other substance abuse or dependence in the 3 months preceding enrollment. This will be self-report.
Diagnosis of dementia, mental retardation, or other neurological or medical conditions known to affect neurophysiologic or neurocognitive functioning, or autoimmune disease
Other major DSM-IV-TR Axis I Disorder
Medical problems that interfere with a participant's ability to complete the assessments
Plans to move out of the San Diego county area within the following 6 months
Diagnosis of OSA and currently receiving APAP, CPAP, or any treatment from a physician.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

UCSD — La Jolla, California

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗