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

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT01785303

Collaborator

Stanford University (Other), National Jewish Health (Other), Rush University Medical Center (Other)

121

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Insomnia	Behavioral: CBT-I Procedure: CPAP	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Model A Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.	Behavioral: CBT-I 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. Other Names: CBT for Insomnia CBT Procedure: CPAP 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. Other Names: Continuous Positive Airway Pressure Positive Airway Pressure
Active Comparator: Model B 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 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. Other Names: CBT for Insomnia CBT Procedure: CPAP 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. Other Names: Continuous Positive Airway Pressure Positive Airway Pressure
Other: Model C Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.	Procedure: CPAP 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. Other Names: Continuous Positive Airway Pressure Positive Airway Pressure

Arm

Intervention/Treatment

Active Comparator: Model A

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

Behavioral: CBT-I

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.

Other Names:

CBT for Insomnia

CBT

Procedure: CPAP

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.

Other Names:

Continuous Positive Airway Pressure

Positive Airway Pressure

Active Comparator: Model B

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

Other Names:

CBT for Insomnia

CBT

Procedure: CPAP

Other Names:

Continuous Positive Airway Pressure

Positive Airway Pressure

Other: Model C

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

Procedure: CPAP

Other Names:

Continuous Positive Airway Pressure

Positive Airway Pressure

Outcome Measures

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Polysomnography (PSG) [End of phase 1 (1 month after baseline assessment)]
Improvement in PSG sleep efficiency at the end of Phase I
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
Actigraphy [90 days after CPAP initiation]
Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation.

Other Outcome Measures

Fatigue Severity Scale (FSS) [90 days after CPAP initiation]
Improvement in FSS from baseline to 90 days after CPAP initiation (End of Phase II).
Epworth Sleepiness Scale (ESS) [90 days after CPAP initiation]
Improvement in ESS from baseline to 90 days after CPAP initiation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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