Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
MATRICS
Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
1 other identifier
interventional
121
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedMarch 18, 2019
March 1, 2019
5.7 years
January 31, 2013
March 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
CPAP adherence
CPAP adherence is defined as % nights used and hrs per night and % of "good users" (≥ 4 hours on ≥ 70% of nights)
90 days after CPAP initiation
Pittsburgh Sleep Quality Index (PSQI)
Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation.
90 days after CPAP initiation
Secondary Outcomes (4)
Polysomnography (PSG)
End of phase 1 (1 month after baseline assessment)
Insomnia Severity Index (ISI)
90 days after CPAP initiation
Functional Outcomes of Sleep Questionnaire (FOSQ)
90 days after CPAP initiation
Actigraphy
90 days after CPAP initiation
Other Outcomes (2)
Fatigue Severity Scale (FSS)
90 days after CPAP initiation
Epworth Sleepiness Scale (ESS)
90 days after CPAP initiation
Study Arms (3)
Model A
ACTIVE COMPARATORModel A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.
Model B
ACTIVE COMPARATORModel 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
OTHERModel C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Males and Females age 18 and older.
- Meets criteria for Obstructive Sleep Apnea
- Meets criteria for an Insomnia Disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Stanford Universitycollaborator
- National Jewish Healthcollaborator
- Rush University Medical Centercollaborator
Study Sites (1)
Center for Circadian and Sleep Medicine, Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (2)
Turner AD, Ong JC, Jones AL, Tu A, Salanitro M, Crawford MR. Neurocognitive functioning in comorbid insomnia and sleep apnea patients is better after positive airway pressure therapy, but worse after cognitive behavioral therapy for insomnia: exploratory analysis of cognitive outcomes from the Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea study. Sleep. 2023 Aug 14;46(8):zsad128. doi: 10.1093/sleep/zsad128.
PMID: 37148183DERIVEDTu 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.
PMID: 34648425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Ong, PhD
Northwestern University Feinberg School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 7, 2013
Study Start
February 1, 2013
Primary Completion
October 1, 2018
Study Completion
February 1, 2019
Last Updated
March 18, 2019
Record last verified: 2019-03