Obstructive Sleep Apnea Treatment in Serious Mental Illness

NCT05457127 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 800600
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Serious mental illness; aging; positive airway pressure

Outcome Measures

Primary Outcomes (5)

• Acceptance of PAP trial

  Acceptance of PAP trial (based on post-adherence program survey taken after the completion of the 4 sessions.) Acceptability will be rated by % individuals who rate high level of satisfaction with the intervention.

  3 months

• OSA self-efficacy using the SEMSA

  OSA self-efficacy will be assessed using the Self-Efficacy Measure for Sleep Apnea (SEMSA). The SEMSA is a 26-item, self-administered questionnaire. The SEMSA has 3 categories: perceived risk, outcome expectancies, and treatment self-efficacy. In the perceived risk category, individuals answer questions about their perceived vulnerability to health risks. In the outcome expectancies, individuals answer questions regarding the potential behavior to reduce those risks, and in the treatment self-efficacy, the participant rates the level of validity of the statements on a 4-point scale regarding their perceived ability to perform behavior. Each of the 3 categories has a 4-point ordinal scale (1= irrelevant, 4 = extremely relevant) ranging from very low to very high. The mean of the 3 subscales are calculated. Higher scores indicate greater perceived self-efficacy, perceived response efficacy, and higher perceived susceptibility.

  3 months

• PAP usage

  PAP usage will be assessed using mean hours/night - which will be obtained from the PAP machine data.

  3 months

• Cognitive Functioning

  Cognitive functioning will be measured with the MATRICS Cognitive Consensus Battery (MCCB).159 The MCCB assesses six cognitive domains (attention/vigilance\*\*, verbal learning/memory\*\*, processing speed, working memory, auditory learning/memory, and reasoning), and has excellent test-retest reliability (ICC = 0.88) with minimal practice effects.159, 160 Executive functioning is the one cognitive domain that is less ideally covered within the MCCB. The closest MCCB domain, reasoning, is measured by a single timed-mazes task that can be readily affected by non-executive functions. We use subtests from the Delis-Kaplan Executive Functioning System (D-KEFS) battery161 \[Color Word Interference, Letter Number Sequencing, and phonemic (FAS) and semantic (Animals) fluency\] to assess Executive Functioning\*. We have successfully employed these measures as a supplement to the MCCB in multiple prior studies in PwS.

  3 months

• Monitoring Slow Wave Sleep and Sleep Spindle Density

  Slow wave sleep -based on proportion/duration of Slow wave activity on overnight sleep EEG recordings. Sleep Spindle density - based on sleep spindle density measured during non-REM sleep on overnight sleep EEG recordings

  3 months

Study Arms (1)

Automatic Positive Airway Pressure (APAP) device

EXPERIMENTAL

Device: Automatic Positive Airway Pressure (APAP)

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.

Automatic Positive Airway Pressure (APAP) device

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Control participants:
• lifetime absence of major psychiatric illness
• 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
• years old
• be at risk or have a diagnosis of obstructive sleep apnea.

You may not qualify 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Central Study Contacts

Ellen Lee, M.D.

CONTACT

858-314-8126; eel013@health.ucsd.edu

Stephanie Ibrahim

CONTACT

(858) 255-0721; sribrahim@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 13, 2022
• Study Start: January 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

US (1)