Schizoaffective DisorderNCT05457127
Obstructive Sleep Apnea Treatment in Serious Mental Illness
A study testing Automatic Positive Airway Pressure (APAP) in people with Schizoaffective Disorder and Schizophrenia, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia, Bipolar Disorder
- What is being tested?
- Automatic Positive Airway Pressure (APAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- must not be conservatized
- 40 - 70 years old
- be at risk or have a diagnosis of obstructive sleep apnea.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCSD
La Jolla, California, 92037
Stephanie Ibrahim, 858-255-0721, sribrahim@health.ucsd.edu
About this study
Official title: Obstructive Sleep Apnea Treatment in People Aging With Serious Mental Illness
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.
Read the 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
- Being tested
- Automatic Positive Airway Pressure (APAP)
- Keywords
- Serious mental illness, aging, positive airway pressure
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Automatic Positive Airway Pressure (APAP) device | Experimental | Not described Receives: Device: Automatic Positive Airway Pressure (APAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
PAP usage
PAP usage will be assessed using mean hours/night - which will be obtained from the PAP machine data.
Measured: 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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jan 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Lee, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457127
- Sponsor's protocol ID
- 800600
- Status last verified
- Jul 2024
- First submitted
- 22 Jun 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Treatment in People Aging With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT05457127
- Acronym / sponsor ID
- 800600
- Conditions
- Schizoaffective Disorder, Schizophrenia, Bipolar Disorder, Obstructive Sleep Apnea of Adult
- Keywords
- Serious mental illness, aging, positive airway pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automatic Positive Airway Pressure (APAP) device | Experimental | Device: Automatic Positive Airway Pressure (APAP) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- lifetime absence of major psychiatric illness
- 40 to 70 years old
- be at risk for or have a diagnosis of obstructive sleep apnea
- diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- must not be conservatized
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Automatic Positive Airway Pressure (APAP) device |
Primary outcome
Acceptance of PAP trial
Time frame: 3 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 SEMSA
Time frame: 3 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 usage
Time frame: 3 months
PAP usage will be assessed using mean hours/night - which will be obtained from the PAP machine data.
Cognitive Functioning
Time frame: 3 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 Density
Time frame: 3 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Positive Airway Pressure (APAP) in people with Schizoaffective Disorder and Schizophrenia, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen Lee, M.D. (858-314-8126, eel013@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of PAP trial (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.