Summary

Eligibility
for people ages 40-70 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Ellen Lee
Headshot of Ellen Lee
Ellen Lee

Description

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.

Official Title

Obstructive Sleep Apnea Treatment in People Aging With Serious Mental Illness

Details

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.

Keywords

Schizoaffective Disorder Schizophrenia Bipolar Disorder Obstructive Sleep Apnea of Adult Serious mental illness aging positive airway pressure Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Disease Psychotic Disorders Mental Disorders Automatic Positive Airway Pressure (APAP) Automatic Positive Airway Pressure (APAP) device

Eligibility

You can join if…

Open to people ages 40-70

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:

You CAN'T join if...

  • 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.

Location

  • UCSD
    La Jolla California 92037 United States

Lead Scientist at UCSD

  • Ellen Lee
    Ellen Lee, MD is Assistant Professor of Psychiatry at the University of California, San Diego (UCSD) and a Staff Psychiatrist at the San Diego VA Healthcare System. Her research focuses on the inflammatory mediators of sleep disturbances in older adults with serious mental illnesses.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05457127
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated