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

This study is currently recruiting participants.

See

Contacts and Locations

Verified September 2017 by Jason Ong, Northwestern University

Sponsor:

Collaborators:

Stanford University

National Jewish Health

Rush University Medical Center

Information provided by (Responsible Party):

Jason Ong, Northwestern University

ClinicalTrials.gov Identifier:

NCT01785303

First received: January 31, 2013

Last updated: September 14, 2017

Last verified: September 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

January 31, 2013

Last Updated Date

September 14, 2017

Start Date ^ICMJE

February 2013

Estimated Primary Completion Date

September 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CPAP adherence [ Time Frame: 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) [ Time Frame: 90 days after CPAP initiation ]
Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01785303 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

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

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea

Official Title ^ICMJE

Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Obstructive Sleep Apnea
Insomnia

Intervention ^ICMJE

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

Study Arms

Active Comparator: Model A
Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.
Interventions:
- Behavioral: CBT-I
- Procedure: CPAP
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.
Interventions:
- Behavioral: CBT-I
- Procedure: CPAP
Model C
Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.

Intervention: Procedure: CPAP

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

140

Estimated Completion Date

December 2018

Estimated Primary Completion Date

September 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bonnie Yap, MS	312-503-6627	matrics@northwestern.edu
Contact: Jason Ong, PhD	312-503-6627	matrics@northwestern.edu

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01785303

Other Study ID Numbers ^ICMJE

1R01HL114529-01( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Jason Ong, Northwestern University

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

Stanford University
National Jewish Health
Rush University Medical Center

Investigators ^ICMJE

Principal Investigator:

Jason Ong, PhD

Northwestern University Feinberg School of Medicine

PRS Account

Northwestern University

Verification Date

September 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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