Back to resultsMultidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS)
Primary Purpose
Obstructive Sleep Apnea, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring CBT, CPAP, Multidisciplinary Treatment, Combination treatment
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
Sites / Locations
- Center for Circadian and Sleep Medicine, Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Model A
Model B
Model C
Arm Description
Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.
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.
Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.
Outcomes
Primary Outcome Measures
CPAP adherence
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)
Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation.
Secondary Outcome Measures
Polysomnography (PSG)
Improvement in PSG sleep efficiency at the end of Phase I
Insomnia Severity Index (ISI)
Improvement in ISI from baseline to 90 days after CPAP initiation
Functional Outcomes of Sleep Questionnaire (FOSQ)
Improvement in FOSQ from baseline to 90 days after CPAP initiation
Actigraphy
Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation.
Full Information
NCT ID
NCT01785303
First Posted
January 31, 2013
Last Updated
March 14, 2019
Sponsor
Northwestern University
Collaborators
Stanford University, National Jewish Health, Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01785303
Brief Title
Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
Acronym
MATRICS
Official Title
Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Stanford University, National Jewish Health, Rush University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Insomnia
Keywords
CBT, CPAP, Multidisciplinary Treatment, Combination treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Model A
Arm Type
Active Comparator
Arm Description
Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.
Arm Title
Model B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Model C
Arm Type
Other
Arm Description
Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.
Intervention Type
Behavioral
Intervention Name(s)
CBT-I
Other Intervention Name(s)
CBT for Insomnia, CBT
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CPAP
Other Intervention Name(s)
Continuous Positive Airway Pressure, Positive Airway Pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
CPAP adherence
Description
CPAP adherence is defined as % nights used and hrs per night and % of "good users" (≥ 4 hours on ≥ 70% of nights)
Time Frame
90 days after CPAP initiation
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation.
Time Frame
90 days after CPAP initiation
Secondary Outcome Measure Information:
Title
Polysomnography (PSG)
Description
Improvement in PSG sleep efficiency at the end of Phase I
Time Frame
End of phase 1 (1 month after baseline assessment)
Title
Insomnia Severity Index (ISI)
Description
Improvement in ISI from baseline to 90 days after CPAP initiation
Time Frame
90 days after CPAP initiation
Title
Functional Outcomes of Sleep Questionnaire (FOSQ)
Description
Improvement in FOSQ from baseline to 90 days after CPAP initiation
Time Frame
90 days after CPAP initiation
Title
Actigraphy
Description
Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation.
Time Frame
90 days after CPAP initiation
Other Pre-specified Outcome Measures:
Title
Fatigue Severity Scale (FSS)
Description
Improvement in FSS from baseline to 90 days after CPAP initiation (End of Phase II).
Time Frame
90 days after CPAP initiation
Title
Epworth Sleepiness Scale (ESS)
Description
Improvement in ESS from baseline to 90 days after CPAP initiation.
Time Frame
90 days after CPAP initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Ong, PhD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Circadian and Sleep Medicine, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34648425
Citation
Tu AY, Crawford MR, Dawson SC, Fogg LF, Turner AD, Wyatt JK, Crisostomo MI, Chhangani BS, Kushida CA, Edinger JD, Abbott SM, Malkani RG, Attarian HP, Zee PC, Ong JC. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022 Mar 1;18(3):789-800. doi: 10.5664/jcsm.9696.
Results Reference
derived
Learn more about this trial
Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
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