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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Rush University Medical Center
Sponsor:
Collaborators:
Stanford University
National Jewish Health
University of California, San Diego
Information provided by (Responsible Party):
Jason C. Ong, PhD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01785303
First received: January 31, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Insomnia
Behavioral: CBT-I
Procedure: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • CPAP adherence [ Time Frame: 90 days after CPAP initiation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation.


Secondary Outcome Measures:
  • Polysomnography (PSG) [ Time Frame: End of phase 1 (1 month after baseline assessment) ] [ Designated as safety issue: No ]
    Improvement in PSG sleep efficiency at the end of Phase I

  • Insomnia Severity Index (ISI) [ Time Frame: 90 days after CPAP initiation ] [ Designated as safety issue: No ]
    Improvement in ISI from baseline to 90 days after CPAP initiation

  • Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 90 days after CPAP initiation ] [ Designated as safety issue: No ]
    Improvement in FOSQ from baseline to 90 days after CPAP initiation

  • Actigraphy [ Time Frame: 90 days after CPAP initiation ] [ Designated as safety issue: No ]
    Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation.


Other Outcome Measures:
  • Fatigue Severity Scale (FSS) [ Time Frame: 90 days after CPAP initiation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Improvement in ESS from baseline to 90 days after CPAP initiation.


Estimated Enrollment: 140
Study Start Date: February 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 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 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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785303

Contacts
Contact: Megan Crawford, PhD 312-942-0549 matrics@rush.edu
Contact: Jason Ong, PhD 312-942-0549 jason_ong@rush.edu

Locations
United States, Illinois
Sleep Disorders Center, Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Stanford University
National Jewish Health
University of California, San Diego
Investigators
Principal Investigator: Jason Ong, PhD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Jason C. Ong, PhD, Assistant Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01785303     History of Changes
Other Study ID Numbers: 1R01HL114529-01
Study First Received: January 31, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Rush University Medical Center:
CBT
CPAP
Multidisciplinary Treatment
Combination treatment

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014