Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05620069
Status:
COMPLETED
Last Update Posted:
2022-11-17
First Post:
2019-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music Listening and Sleep in Rehabilitation of People With Acquired Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2019-01-31', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'Change from baseline to after the 14-days intervention period', 'description': 'Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.'}, {'measure': 'Objective sleep quality', 'timeFrame': 'Change from baseline to after the 14-days intervention period', 'description': 'Measured with wrist-worn actigraphy registrering body movements from which you can derive the sleep-wake pattern.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain injury', 'Acquired brain injury', 'Sleep disturbance', 'Music', 'Music therapy'], 'conditions': ['Brain Injuries', 'Sleep Disturbance']}, 'descriptionModule': {'briefSummary': 'An Injury to the brain may lead to sleep-wake disturbances which may negatively influence functional recovery, quality of life and general rehabilitation.\n\nThe purpose of this study is to investigate the effect of music listening on sleep disturbances after acquired brain injury (ABI).\n\nDuring a 2 week intervention period patients with ABI will listen to music for appr. 30 minutes before going to sleep. Records of their sleep quality are compared to records of sleep quality from 2 weeks without music intervention.\n\nH1 Hypothesis: Music listening (ML) improves sleep quality after ABI in patients.\n\nH0 Hypothesis: Music listening (ML) has no effect on sleep quality after ABI in patients.', 'detailedDescription': 'Participants are recruited from Vejlefjord Rehabilitation - a neurorehabilitation center in Denmark.\n\nPatients who meet the inclusion criteria are enrolled in the study after informed consent. Participants are randomly allocated to two conditions (ML+Treatment as usual (TAU) or TAU only in a crossover design. Randomization is done by sealed envelope, and after two weeks of either ML+TAU or TAU the participants switch condition.\n\nParticipants are asked to select one of four music playlists and listen to it for appr. 30 minutes at bedtime during the intervention period. Participants will rate sleep quality and liking of the intervention.\n\nInformation about injury, demographic and socioeconomic status are derived from patient journals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* in-patients with ABI being treated at Vejlefjord Rehabilitation during the entire project period\n* age \\> 18 years\n* sleep-wake disturbances corresponding a score of 5 or more on Pittsburgh Sleep Quality Index (PSQI).\n* Mentally and physically capable of administering music equipment, actigraph and self-report questionnaires.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05620069', 'briefTitle': 'Music Listening and Sleep in Rehabilitation of People With Acquired Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Vejlefjord Rehabilitation'}, 'officialTitle': 'The Effect of Listening to Music on Sleep Disturbances in Patients With Acquired Brain Injuries', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music listening at bed time', 'interventionNames': ['Other: Music listening']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual'}], 'interventions': [{'name': 'Music listening', 'type': 'OTHER', 'description': 'Participants are asked to select one of four music playlists and listen to it for appr. 30 minutes at bedtime during the intervention period.', 'armGroupLabels': ['Music listening at bed time']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7140', 'city': 'Stouby', 'country': 'Denmark', 'facility': 'Vejlefjord Rehabilitation', 'geoPoint': {'lat': 56.70737, 'lon': 9.08699}}], 'overallOfficials': [{'name': 'Mette Underbjerg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vejlefjord Rehabilitation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejlefjord Rehabilitation', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Aalborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research and Development', 'investigatorFullName': 'Mette Underbjerg', 'investigatorAffiliation': 'Vejlefjord Rehabilitation'}}}}