What side effects are associated with this type of intervention?

Continuous Positive Airway Pressure (CPAP) therapy, a common treatment for Obstructive Sleep Apnea (OSA), can have side effects such as nasal congestion, dry mouth, skin irritation from the mask, and discomfort while wearing the device. Some patients may also experience claustrophobia or difficulty tolerating the air pressure. Oral appliances, another treatment option, can cause jaw discomfort, teeth shifting, and excessive salivation. Medications used to manage residual excessive daytime sleepiness in OSA patients, such as modafinil, can lead to headaches, nausea, and anxiety.

What prior FDA approvals exist?

The primary FDA-approved treatment for Obstructive Sleep Apnea (OSA) is Continuous Positive Airway Pressure (CPAP) therapy, which is widely recognized for its efficacy in maintaining open airways during sleep. Other treatments include oral appliances, which reposition the jaw to keep the airway open, and surgical options. While various pharmacologic agents have been investigated, none have proven effective enough to replace CPAP therapy. Thus, CPAP remains the cornerstone of OSA management.

What other types of research exist?

Promising novel alternatives to CPAP therapy for OSA treatment include: 1) Oral appliance therapy, which has shown cardiovascular benefits and improved adherence in some patients. 2) Adenotonsillectomy, particularly effective in children, improving behavior and quality of life. 3) Weight loss programs, which can significantly reduce OSA severity. 4) Positive airway pressure therapy variations, such as different modes of PAP, which may improve adherence and efficacy. These alternatives offer potential benefits and should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Positive Airway Pressure Device

APAP for Obstructive Sleep Apnea in Mental Illness

Phase 2

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

40 to 70 years old

be at risk for or have a diagnosis of obstructive sleep apnea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment called Positive Airway Pressure (PAP) for adults with serious mental illnesses like schizophrenia and bipolar disorder who also have sleep apnea. PAP treatment uses a machine to help keep the airways open during sleep by providing a steady stream of air through a mask. The study aims to see if this treatment can improve cognitive function and overall health in these patients over several months. Positive Airway Pressure (PAP) is the standard and most effective treatment for obstructive sleep apnea (OSA).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While APAP is generally safe, side effects can include discomfort, nasal congestion, dry mouth, headaches, and sometimes difficulty sleeping when getting used to the machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 70 years old.

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

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

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I am between 40 and 70 years old.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptance of PAP trial

Cognitive Functioning

Monitoring Slow Wave Sleep and Sleep Spindle Density

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Automatic Positive Airway Pressure (APAP) deviceExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Continuous Positive Airway Pressure (CPAP) therapy is the most common treatment for Obstructive Sleep Apnea (OSA). It works by delivering a constant stream of air through a mask, which keeps the airway open during sleep, preventing apneas and hypopneas. This is crucial for OSA patients as it reduces daytime sleepiness, improves cognitive function, and lowers cardiovascular risks. Oral appliances, which reposition the jaw to keep the airway open, and pharmacologic agents, which aim to reduce airway collapsibility or stimulate respiratory drive, are also used but are generally less effective than CPAP. These treatments are essential as they address the underlying airway obstruction, improving overall health and quality of life for OSA patients.

Sleep-disordered breathing and resistant hypertension.Cardiovascular outcomes of CPAP therapy in obstructive sleep apnea syndrome.