NCT05457127

Obstructive Sleep Apnea Treatment in Serious Mental Illness

Obstructive Sleep Apnea Treatment in People Aging With Serious Mental Illness

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Sleep disturbances are central to many psychiatric disorders, including schizophrenia and bipolar disorder, with clear implications for cognition, brain health, physical health and aging. Obstructive sleep apnea (OSA) is typically underdiagnosed and undertreated due to impairment from psychiatric symptoms, limited resources, and stigma. In turn, consequences of untreated OSA in SMI are dire: in particular, worsening cardiometabolic health, cognitive decline, and death. Few studies have examined the impact of treatments for obstructive sleep apnea on cognitive problems in a high-risk group, such as older adults with SMI. The goals of the proposed study are to assess the acceptance and effectiveness of positive airway pressure (PAP) treatment for OSA, and its impact on cognitive and cardiometabolic outcomes as well as biological processes over a 3-month period. In order to determine eligibility, participants will be asked to complete a diagnostic test either at home or overnight in-lab. If diagnosed with sleep apnea, the participant will be offered a 3-month treatment with an automatic PAP. In addition, eligible participants will complete weekly check-ins with study staff and a series of detailed interviews, physical and neuropsychological tests, instrumental and clinical assessments, and blood draws every month for a total of 3 months.

Conditions

• Schizoaffective Disorder
• Schizophrenia
• Bipolar Disorder
• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DEVICE	Automatic Positive Airway Pressure (APAP)	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-07-13
• Last updated: 2024-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study