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

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

Tracking Information

• First Submitted Date: January 31, 2013
• First Posted Date: February 7, 2013
• Last Update Posted Date: March 18, 2019
• Actual Study Start Date: February 2013
• Actual Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01785303 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: 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: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Obstructive Sleep Apnea
• Insomnia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2019): 121
• Original Estimated Enrollment (submitted: February 4, 2013): 140
• Actual Study Completion Date: February 2019
• Actual Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01785303
• Other Study ID Numbers: 1R01HL114529-01( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jason Ong, Northwestern University
• Study Sponsor: Northwestern University

Collaborators

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

Investigators

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

• PRS Account: Northwestern University
• Verification Date: March 2019