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Completed

NCT Number: NCT01785303

Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Insomnia Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Circadian and Sleep Medicine, Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-I

Behavioral

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

cPAP

Procedure

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

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Polysomnography (PSG)

    Time frame: End of phase 1 (1 month after baseline assessment)

    Improvement in PSG sleep efficiency at the end of Phase I

  2. Insomnia Severity Index (ISI)

    Time frame: 90 days after CPAP initiation

    Improvement in ISI from baseline to 90 days after CPAP initiation

  3. Functional Outcomes of Sleep Questionnaire (FOSQ)

    Time frame: 90 days after CPAP initiation

    Improvement in FOSQ from baseline to 90 days after CPAP initiation

  4. Actigraphy

    Time frame: 90 days after CPAP initiation

    Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation.

Other outcomes

  1. 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).

  2. Epworth Sleepiness Scale (ESS)

    Time frame: 90 days after CPAP initiation

    Improvement in ESS from baseline to 90 days after CPAP initiation.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Jewish Health
  • Rush University Medical Center
  • Stanford University

Registry information

Official study title

Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia

Acronym: MATRICS

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Feb 7, 2013
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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