Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS)

Northwestern University

Status: Completed

Conditions: Insomnia; Obstructive Sleep Apnea

Treatments: Procedure: CPAP; Behavioral: CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT01785303

1R01HL114529-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 3 patient groups

Model A

Active Comparator group

Description:

Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.

Treatment:

Behavioral: CBT-I

Procedure: CPAP

Model B

Active Comparator group

Description:

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.

Treatment:

Behavioral: CBT-I

Procedure: CPAP

Model C

Other group

Description:

Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.

Treatment:

Procedure: CPAP