Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Model A	CBT-I	Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.
Model B	CPAP	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.
Model A	CPAP	Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.
Model B	CBT-I	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.
Model C	CPAP	Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (1): Center for Circadian and Sleep Medicine, Northwestern University
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Chicago, Illinois, United States

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