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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 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 15, 2016
Last verified: September 2016
January 31, 2013
September 15, 2016
February 2013
September 2017   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01785303 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
  • 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.
Same as current
 
Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Insomnia
  • 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 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2017
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Christine Smith, MA 312-503-6628 MATRICS@northwestern.edu
Contact: Jason Ong, PhD 312-503-6612 jason.ong@northwestern.edu
United States
 
 
NCT01785303
1R01HL114529-01( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Jason Ong, Northwestern University
Northwestern University
  • Stanford University
  • National Jewish Health
  • Rush University Medical Center
Principal Investigator: Jason Ong, PhD Northwestern University Feinberg School of Medicine
Northwestern University
September 2016

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