Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea

Study Overview
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Brief Summary
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The overall goal of this project is to determine the efficacy of a multidisciplinary treatment model for patients with Obstructive Sleep Apnea (OSA) and comorbid Insomnia. Specific Aim 1: To determine the efficacy of a treatment model combining Cognitive Behavioral Therapy (CBT) and Continued Positive Airway Pressure(CPAP) for individuals with OSA and comorbid insomnia. Specific Aim 2: To determine if there are relative benefits in the sequence of treatment initiation. Specific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.

Detailed Description
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OSA is a sleep-related breathing disorder that is growing in prevalence and is associated with negative cardiovascular consequences and adverse events from excessive daytime sleepiness. Insomnia is a frequently co-occurring sleep disorder that adds significant morbidity and is a potential barrier to adherence of OSA treatment. It is currently unknown if direct treatment of insomnia will enhance outcomes of OSA treatment. The investigators at the Rush Sleep Disorders Center have developed an approach that combines CBT for insomnia delivered by a psychologist with CPAP therapy managed by a physician. Building upon preliminary data collected in the clinic, the investigators seek to test the efficacy and mechanisms of this multidisciplinary model against the standard practice of treating OSA using CPAP alone.

Official Title
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Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia

Conditions
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Obstructive Sleep Apnea, Insomnia

Intervention / Treatment
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* Behavioral: CBT-I
* Procedure: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females age 18 and older. Meets criteria for Obstructive Sleep Apnea Meets criteria for an Insomnia Disorder Exclusion Criteria: Comorbid medical condition that requires immediate treatment of OSA Severe cases of OSA that require immediate treatment Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment Comorbid sleep disorders that require treatment outside of the study protocol Other sleep-related breathing disorder besides OSA Excessive daytime sleepiness that requires immediate treatment or presents significant risk CPAP use or formal CBT for insomnia within the past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Model A<br>Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II. | Behavioral: CBT-I<br>* Cognitive Behavior Therapy for Insomnia (CBT-I) consists of 4 weekly sessions delivered individually. The focus of these sessions is on modifying behaviors and cognitions related to sleep and insomnia.<br>* Other names: CBT;Procedure: CPAP<br>* CPAP is an FDA-approved medical device used to treat obstructive sleep apnea. This device consists of a mask, hose, and machine that blows continuous air which maintains a consistent pressure of airflow preventing the upper airway from collapsing during sleep.<br>* Other names: Positive Airway Pressure;|
| Active Comparator: Model B<br>Model B consists of 4 weeks of monitoring using sleep diaries in Phase I. Phase II consists of concurrent initiation of CBT-I and CPAP for OSA. | Behavioral: CBT-I<br>* Cognitive Behavior Therapy for Insomnia (CBT-I) consists of 4 weekly sessions delivered individually. The focus of these sessions is on modifying behaviors and cognitions related to sleep and insomnia.<br>* Other names: CBT;Procedure: CPAP<br>* CPAP is an FDA-approved medical device used to treat obstructive sleep apnea. This device consists of a mask, hose, and machine that blows continuous air which maintains a consistent pressure of airflow preventing the upper airway from collapsing during sleep.<br>* Other names: Positive Airway Pressure;|
| Other: Model C<br>Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA. | Procedure: CPAP<br>* CPAP is an FDA-approved medical device used to treat obstructive sleep apnea. This device consists of a mask, hose, and machine that blows continuous air which maintains a consistent pressure of airflow preventing the upper airway from collapsing during sleep.<br>* Other names: Positive Airway Pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP adherence | CPAP adherence is defined as % nights used and hrs per night and % of good users (≥ 4 hours on ≥ 70% of nights) | 90 days after CPAP initiation | 
| Pittsburgh Sleep Quality Index (PSQI) | Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation. | 90 days after CPAP initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography (PSG) | Improvement in PSG sleep efficiency at the end of Phase I | End of phase 1 (1 month after baseline assessment) | 
| Insomnia Severity Index (ISI) | Improvement in ISI from baseline to 90 days after CPAP initiation | 90 days after CPAP initiation | 
| Functional Outcomes of Sleep Questionnaire (FOSQ) | Improvement in FOSQ from baseline to 90 days after CPAP initiation | 90 days after CPAP initiation | 
| Actigraphy | Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation. | 90 days after CPAP initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, CPAP, Multidisciplinary Treatment, Combination treatment