Obstructive Sleep ApneaMATRICSNCT01785303
Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
A study testing CBT-I and CPAP in people with Obstructive Sleep Apnea and Insomnia, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Insomnia
- What is being tested?
- CBT-I and CPAP
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females age 18 and older.
- Meets criteria for Obstructive Sleep Apnea
- Meets criteria for an Insomnia Disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Circadian and Sleep Medicine, Northwestern University
Chicago, Illinois, 60611
About this study
Official title: Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Insomnia
- Being tested
- CBT-I, CPAP
- Keywords
- CBT, CPAP, Multidisciplinary Treatment, Combination treatment
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
Also called CBT for Insomnia, CBT
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.
CPAPProcedure or surgery
Also called Continuous Positive Airway Pressure, Positive Airway Pressure
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.
| Study group | Role | What they receive |
|---|---|---|
| Model A | Active comparator | Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II. Receives: Behavioral: CBT-I; Procedure: CPAP |
| Model B | Active comparator | 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. Receives: Behavioral: CBT-I; Procedure: CPAP |
| Model C | Other | Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA. Receives: Procedure: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP adherence
CPAP adherence is defined as % nights used and hrs per night and % of "good users" (≥ 4 hours on ≥ 70% of nights)
Measured: 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.
Measured: 90 days after CPAP initiation
Secondary outcomes (4)
Polysomnography (PSG)
Improvement in PSG sleep efficiency at the end of Phase I
Measured: End of phase 1 (1 month after baseline assessment)
Insomnia Severity Index (ISI)
Improvement in ISI from baseline to 90 days after CPAP initiation
Measured: 90 days after CPAP initiation
Functional Outcomes of Sleep Questionnaire (FOSQ)
Improvement in FOSQ from baseline to 90 days after CPAP initiation
Measured: 90 days after CPAP initiation
Actigraphy
Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation.
Measured: 90 days after CPAP initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Jewish Health, Rush University Medical Center
- Responsible party
- Principal investigator, Jason Ong, Northwestern University
- Investigators
- Jason Ong, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785303
- Sponsor's protocol ID
- 1R01HL114529-01
- Acronym
- MATRICS
- Status last verified
- Mar 2019
- First submitted
- 31 Jan 2013
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37148183Tu 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.
PubMed 34648425
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
- ClinicalTrials.gov ID
- NCT01785303
- Acronym / sponsor ID
- MATRICS / 1R01HL114529-01
- Conditions
- Obstructive Sleep Apnea, Insomnia
- Keywords
- CBT, CPAP, Multidisciplinary Treatment, Combination treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Stanford University, National Jewish Health, Rush University Medical Center
- Study start
- Feb 2013 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Model A | Active comparator | Behavioral: CBT-I, Procedure: CPAPModel A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II. |
| Model B | Active comparator | Behavioral: CBT-I, Procedure: CPAPModel 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 | Other | Procedure: CPAPModel C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females age 18 and older.
- Meets criteria for Obstructive Sleep Apnea
- Meets criteria for an Insomnia Disorder
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-IAlso: CBT for Insomnia, CBTCognitive 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. | Behavioural | Model A, Model B |
| CPAPAlso: Continuous Positive Airway Pressure, Positive Airway PressureCPAP 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. | Procedure or surgery | Model A, Model B, Model C |
Primary outcome
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.
4 secondary outcomes
Polysomnography (PSG)
Time frame: End of phase 1 (1 month after baseline assessment)
Insomnia Severity Index (ISI)
Time frame: 90 days after CPAP initiation
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 90 days after CPAP initiation
Actigraphy
Time frame: 90 days after CPAP initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Derived from this study: PubMed 37148183Turner 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.
- Derived from this study: PubMed 34648425Tu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Ong, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I and CPAP in people with Obstructive Sleep Apnea and Insomnia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP adherence (time frame: 90 days after CPAP initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785303, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.