Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-05-27 @ 8:05 PM
Study NCT ID:
NCT01785303
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2013-01-31', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': '90 days after CPAP initiation', 'description': 'Improvement in FSS from baseline to 90 days after CPAP initiation (End of Phase II).'}, {'measure': 'Epworth Sleepiness Scale (ESS)', 'timeFrame': '90 days after CPAP initiation', 'description': 'Improvement in ESS from baseline to 90 days after CPAP initiation.'}], 'primaryOutcomes': [{'measure': 'CPAP adherence', 'timeFrame': '90 days after CPAP initiation', 'description': 'CPAP adherence is defined as % nights used and hrs per night and % of "good users" (≥ 4 hours on ≥ 70% of nights)'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '90 days after CPAP initiation', 'description': 'Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation.'}], 'secondaryOutcomes': [{'measure': 'Polysomnography (PSG)', 'timeFrame': 'End of phase 1 (1 month after baseline assessment)', 'description': 'Improvement in PSG sleep efficiency at the end of Phase I'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': '90 days after CPAP initiation', 'description': 'Improvement in ISI from baseline to 90 days after CPAP initiation'}, {'measure': 'Functional Outcomes of Sleep Questionnaire (FOSQ)', 'timeFrame': '90 days after CPAP initiation', 'description': 'Improvement in FOSQ from baseline to 90 days after CPAP initiation'}, {'measure': 'Actigraphy', 'timeFrame': '90 days after CPAP initiation', 'description': 'Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CBT', 'CPAP', 'Multidisciplinary Treatment', 'Combination treatment'], 'conditions': ['Obstructive Sleep Apnea', 'Insomnia']}, 'referencesModule': {'references': [{'pmid': '37148183', 'type': 'DERIVED', 'citation': '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': '34648425', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSpecific 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.\n\nSpecific Aim 2: To determine if there are relative benefits in the sequence of treatment initiation.\n\nSpecific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females age 18 and older.\n* Meets criteria for Obstructive Sleep Apnea\n* Meets criteria for an Insomnia Disorder\n\nExclusion Criteria:\n\n* Comorbid medical condition that requires immediate treatment of OSA\n* Severe cases of OSA that require immediate treatment\n* Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment\n* Comorbid sleep disorders that require treatment outside of the study protocol\n* Other sleep-related breathing disorder besides OSA\n* Excessive daytime sleepiness that requires immediate treatment or presents significant risk\n* CPAP use or formal CBT for insomnia within the past 6 months'}, 'identificationModule': {'nctId': 'NCT01785303', 'acronym': 'MATRICS', 'briefTitle': 'Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia', 'orgStudyIdInfo': {'id': '1R01HL114529-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL114529-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Model A', 'description': 'Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.', 'interventionNames': ['Behavioral: CBT-I', 'Procedure: CPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model B', '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.', 'interventionNames': ['Behavioral: CBT-I', 'Procedure: CPAP']}, {'type': 'OTHER', 'label': 'Model C', 'description': 'Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.', 'interventionNames': ['Procedure: CPAP']}], 'interventions': [{'name': 'CBT-I', 'type': 'BEHAVIORAL', 'otherNames': ['CBT for Insomnia', 'CBT'], '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.', 'armGroupLabels': ['Model A', 'Model B']}, {'name': 'CPAP', 'type': 'PROCEDURE', 'otherNames': ['Continuous Positive Airway Pressure', 'Positive Airway Pressure'], '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.', 'armGroupLabels': ['Model A', 'Model B', 'Model C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Center for Circadian and Sleep Medicine, Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jason Ong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'National Jewish Health', 'class': 'OTHER'}, {'name': 'Rush University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jason Ong', 'investigatorAffiliation': 'Northwestern University'}}}}