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

March 14, 2019 updated by: Jason Ong, Northwestern University

Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Center for Circadian and Sleep Medicine, Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
  • CBT for Insomnia
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
  • CBT for Insomnia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
90 days after CPAP initiation
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.
90 days after CPAP initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography (PSG)
Time Frame: End of phase 1 (1 month after baseline assessment)
Improvement in PSG sleep efficiency at the end of Phase I
End of phase 1 (1 month after baseline assessment)
Insomnia Severity Index (ISI)
Time Frame: 90 days after CPAP initiation
Improvement in ISI from baseline to 90 days after CPAP initiation
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
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.
90 days after CPAP initiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
90 days after CPAP initiation
Epworth Sleepiness Scale (ESS)
Time Frame: 90 days after CPAP initiation
Improvement in ESS from baseline to 90 days after CPAP initiation.
90 days after CPAP initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Rush University Medical Center
Stanford University
National Jewish Health

Investigators

  • Principal Investigator: Jason Ong, PhD, Northwestern University Feinberg School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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