Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT04306835
Status:
UNKNOWN
Last Update Posted:
2020-03-13
First Post:
2020-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'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'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of drop-outs in patients participating in the study.', 'timeFrame': '12 weeks', 'description': "Patiënt who don't use there CPAP anymore."}, {'measure': 'CPAP habituation in patients participating in the study.', 'timeFrame': '12 weeks', 'description': 'The speed of CPAP habituation is determined by reading the CPAP device.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia', 'Obstructive Sleep Apnea', 'Cognitive Behavioral Therapy', 'Continuous Positive Airway Pressure']}, 'descriptionModule': {'briefSummary': 'Patients follow the fully standard sleep test according to the normal procedure. This means that they undergo a polysomnography and fill in a questionnaire. If according to the questionnaire, there is insomnia, the patient also receives an intake interview to check whether this is indeed the case. If the patient has both disorders and meets the inclusion and exclusion criteria, they will be asked to sign the informed consent. If the patient agrees, the CPAP-therapy will be started as usual, simultaneously with CGT-i. The latter will last 7 weeks and will cover the following points: psycho-education, sleep restriction and sleep hygiene, cognition, relaxation and relapse prevention. Because of the design of this study (starting CGT-I as soon as possible after the diagnosis of OSAS) and the groups already planned for CBT-I, it is not possible for all participants to participate in group cognitive behavioral therapy, therefore individual sessions were provided for these participants. The patient comes for monitoring at set times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients, male and female, with an OSAS diagnosed by full polysomnography and insomnia diagnosed by questionnaires.\n* Age between 18 and 75 years\n* Dutch as native language\n\nExclusion Criteria:\n\n* Patients younger than 18 years and older than 75 years\n* Patients with a burn-out\n* Patients with restless legs\n* Pregnant woman\n* Patients who work as shift workers\n* Patients with severe psychiatric disorder\n* Patients who take sleep medication, unless it can be reduced and stopped during cognitive behavior therapy\n* Patients with daily alcohol abuse (men \\> 3 drinks on any day or 14 per week, women \\> 2 drinks on any day or 7 per week)'}, 'identificationModule': {'nctId': 'NCT04306835', 'briefTitle': 'The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'The Impact of Cognitive Behavioral Therapy for Insomnia on CPAP Therapy Use and Drop Outs in Obstructive Sleep Apnea Syndrome Patients With Insomnia.', 'orgStudyIdInfo': {'id': '143201836242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPAP + CBT-i', 'description': 'Patients treated simultaneously with CPAP for their OSAS and cognitive behavioral therapy for their insomnia.', 'interventionNames': ['Behavioral: Cognitive behavioural therapy for insomnia']}, {'type': 'NO_INTERVENTION', 'label': 'CPAP only', 'description': 'Patients suffering from OSAS and insomnia, but only treated with CPAP.'}], 'interventions': [{'name': 'Cognitive behavioural therapy for insomnia', 'type': 'BEHAVIORAL', 'description': 'a technique for treating insomnia without medications', 'armGroupLabels': ['CPAP + CBT-i']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050', 'city': 'Jette', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sonia De Weerdt', 'role': 'CONTACT', 'email': 'sonia.deweerdt@uzbrussel.be', 'phone': '024773890'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'centralContacts': [{'name': 'Jasper Molenberghs', 'role': 'CONTACT', 'email': 'jasper.molenberghs@vub.be', 'phone': '0494182014'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}