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

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ClinicalTrials.gov Identifier: NCT01785303
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : March 18, 2019
Sponsor:
Collaborators:
Stanford University
National Jewish Health
Rush University Medical Center
Information provided by (Responsible Party):
Jason Ong, Northwestern University

Tracking Information
First Submitted Date  ICMJE January 31, 2013
First Posted Date  ICMJE February 7, 2013
Last Update Posted Date March 18, 2019
Actual Study Start Date  ICMJE February 2013
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2013)
  • 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
 (submitted: February 4, 2013)
  • 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 Pre-specified Outcome Measures
 (submitted: February 4, 2013)
  • 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 Pre-specified Outcome Measures 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  ICMJE Not Applicable
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  ICMJE
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2019)
121
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2013)
140
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date October 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
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  ICMJE 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 March 2019

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