APAP for Obstructive Sleep Apnea in Mental Illness

Overseen By Stephanie Ibrahim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Substance abuse, Dementia, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how treating sleep apnea—a condition where breathing stops and starts during sleep—can improve brain function in individuals with serious mental illnesses like schizophrenia and bipolar disorder. The treatment under investigation is Automatic Positive Airway Pressure (APAP), a device that keeps airways open during sleep. Individuals with these mental health conditions who are at risk for or have sleep apnea might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to understanding how sleep apnea treatment can benefit mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are already receiving treatment for obstructive sleep apnea, you may not be eligible to participate.

What prior data suggests that the APAP device is safe for treating obstructive sleep apnea in individuals with serious mental illness?

Research shows that Automatic Positive Airway Pressure (APAP) is generally safe for treating obstructive sleep apnea (OSA). Studies have found that similar treatments, such as Continuous Positive Airway Pressure (CPAP), are well-tolerated by most people. Benefits include reduced sleepiness and improved breathing during sleep. However, some users might experience side effects like throat infections, though these are uncommon. This treatment is widely used for OSA. The safety evidence from CPAP supports confidence in APAP's safety, as they function similarly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Automatic Positive Airway Pressure (APAP) is unique because it offers a tailored approach to treating obstructive sleep apnea, especially in individuals with mental illness. Unlike traditional CPAP machines, which deliver a constant air pressure, APAP adjusts the pressure automatically throughout the night based on the user's needs. This can lead to increased comfort and potentially better adherence to therapy, making it an exciting option for those who find standard treatments difficult to tolerate. Researchers are hopeful that APAP's personalized pressure settings will improve sleep quality and mental health outcomes more effectively than conventional methods.

What evidence suggests that the APAP device is effective for obstructive sleep apnea in mental illness?

Research shows that Automatic Positive Airway Pressure (APAP), which participants in this trial will receive, effectively treats obstructive sleep apnea (OSA). Studies have found that APAP keeps the airway open during sleep, reducing OSA severity. This treatment can improve sleep quality, often disrupted in people with OSA. Additionally, using positive airway pressure (PAP) has been linked to better cognitive function and fewer symptoms of depression in individuals with sleep disorders. These benefits are especially important for those with serious mental illnesses, as better sleep can support mental health. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 40-70 with serious mental illnesses like schizophrenia or bipolar disorder, who may also have or be at risk for obstructive sleep apnea. Participants should not have other major psychiatric conditions and must not be under conservatorship.

Inclusion Criteria

I am at risk for or have been diagnosed with obstructive sleep apnea.

I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.

You have never had a serious mental illness in your life.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or at home)

Treatment

Participants receive a 3-month treatment with an automatic Positive Airway Pressure (PAP) device

12 weeks

Weekly check-ins (virtual or in-person), monthly detailed assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Automatic Positive Airway Pressure (APAP)

Trial Overview The study is testing the use of Automatic Positive Airway Pressure (APAP) machines to treat obstructive sleep apnea in individuals with serious mental illnesses, assessing how it might improve their cognitive function.

How Is the Trial Designed?

Group I: Automatic Positive Airway Pressure (APAP) device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6374080/

Treatment of Adult Obstructive Sleep Apnea With Positive ... Overall, the analyses support the conclusion that CPAP is effective in reducing OSA severity as measured by the AHI or RDI, across the spectrum of OSA severity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05457127

Obstructive Sleep Apnea Treatment in Serious Mental ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0954611124002257

and patient-reported outcomes in hypoglossal nerve ... Higher improvement in daytime sleepiness and insomnia was observed in the HGNS group compared to the aPAP group. Abstract. Background. Few data are available ...

4. atsjournals.org atsjournals.org/doi/10.1164/rccm.201212-2223OC

Health Outcomes of Continuous Positive Airway Pressure ... Conclusions: Important health outcomes were similar after 1 month of optimal MAD and CPAP treatment in patients with moderate-severe OSA. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6610775/

Effects of continuous positive airway pressure on depression ... A systematic review of 20 randomised trials including 4255 participants confirmed a benefit of CPAP in reducing depression symptoms in OSA ...

6. withpower.com withpower.com/trial/phase-2-sleep-apnea-obstructive-8-2022-03eab

APAP for Obstructive Sleep Apnea in Mental Illness Continuous Positive Airway Pressure (CPAP), a similar treatment to APAP, has been shown to be safe and effective in treating obstructive sleep apnea in people ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1389945724001096

Real-world impact of continuous positive airway pressure ... EDS and breathing mostly normalized with continuous positive airway pressure (CPAP). Overall, 16% of patients experienced residual EDS after starting CPAP ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/apap-machine

APAP Machine: What It Is, How It Works & Side Effects An APAP (automatic positive airway pressure) machine is a type of medical device that most commonly helps treat obstructive sleep apnea (OSA).

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/resp.13808

Clinical side effects of continuous positive airway pressure ... In one study, OSA patients using CPAP therapy either with or without heated humidity had increased risk of upper airway infections compared to ...