Clinical trial NCT05457127: Obstructive Sleep Apnea Treatment in Serious Mental Illness
Official title: Obstructive Sleep Apnea Treatment in People Aging With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizoaffective Disorder
Schizophrenia
Bipolar Disorder
Obstructive Sleep Apnea of Adult
Keywords: Serious mental illness
aging
positive airway pressure
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Acceptance of PAP trial
timeFrame: 3 months
measure: OSA self-efficacy using the SEMSA
timeFrame: 3 months
measure: PAP usage
timeFrame: 3 months
measure: Cognitive Functioning
timeFrame: 3 months
measure: Monitoring Slow Wave Sleep and Sleep Spindle Density
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
References: