Obstructive Sleep Apnea Treatment in Serious Mental Illness
Primary Purpose
Schizoaffective Disorder, Schizophrenia, Bipolar Disorder
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Automatic Positive Airway Pressure (APAP)
Sponsored by
About this trial
This is an interventional treatment trial for Schizoaffective Disorder focused on measuring Serious mental illness, aging, positive airway pressure
Eligibility Criteria
Inclusion Criteria:
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
- must not be conservatized
- 40 - 70 years old
- be at risk or have a diagnosis of obstructive sleep apnea.
Exclusion Criteria:
- 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.
Sites / Locations
- UCSD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Automatic Positive Airway Pressure (APAP) device
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
PAP usage
PAP usage will be assessed using mean hours/night - which will be obtained from the PAP machine data.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05457127
First Posted
June 22, 2022
Last Updated
July 8, 2022
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT05457127
Brief Title
Obstructive Sleep Apnea Treatment in Serious Mental Illness
Official Title
Obstructive Sleep Apnea Treatment in People Aging With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizoaffective Disorder, Schizophrenia, Bipolar Disorder, Obstructive Sleep Apnea of Adult
Keywords
Serious mental illness, aging, positive airway pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Automatic Positive Airway Pressure (APAP) device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Automatic Positive Airway Pressure (APAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptance of PAP trial
Description
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.
Time Frame
3 months
Title
OSA self-efficacy using the SEMSA
Description
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.
Time Frame
3 months
Title
PAP usage
Description
PAP usage will be assessed using mean hours/night - which will be obtained from the PAP machine data.
Time Frame
3 months
Title
Cognitive Functioning
Description
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.
Time Frame
3 months
Title
Monitoring Slow Wave Sleep and Sleep Spindle Density
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
must not be conservatized
40 - 70 years old
be at risk or have a diagnosis of obstructive sleep apnea.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Lee, M.D.
Phone
858-314-8126
Email
eel013@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexa Hernandez, B.S.
Phone
858-208-0542
Email
ahernandez04@health.ucsd.edu
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulyn Kwak, B.A.
Phone
858-935-4224
Email
pkwak@health.ucsd.edu
12. IPD Sharing Statement
Learn more about this trial
Obstructive Sleep Apnea Treatment in Serious Mental Illness
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