Obstructive Sleep Apnea Treatment in Serious Mental Illness
This study is looking at how well a treatment for obstructive sleep apnea (OSA) works for people with serious mental illnesses like schizophrenia, schizoaffective disorder, or bipolar disorder. OSA is a sleep disorder where breathing repeatedly stops and starts. Participants who are diagnosed with OSA will receive an Automatic Positive Airway Pressure (APAP) device (ResMed Airsense 11 Autoset) for up to 3 months. The study wants to see if people accept this treatment, how much they use the APAP device, and if it helps with their thinking skills. You can join if you are between 40 and 70 years old and have one of these mental illnesses or are a control participant without a major psychiatric illness but at risk for or diagnosed with OSA. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 300 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will complete a diagnostic sleep test. If diagnosed with OSA, you will use an APAP device for 3 months, have weekly check-ins, and monthly interviews, physical and neuropsychological tests, and blood draws.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months, with primary endpoints measured at this time.
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Obstructive Sleep Apnea Treatment in Serious Mental Illness
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
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What this trial measures
- Acceptance of PAP trial3 months
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.
- OSA self-efficacy using the SEMSA3 months
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.
- PAP usage3 months
PAP usage will be assessed using mean hours/night - which will be obtained from the PAP machine data.
- Cognitive Functioning3 months
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.
- Monitoring Slow Wave Sleep and Sleep Spindle Density3 months
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