Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT02524067
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Environment for Agitation in Patients With TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2015-07-08', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agitation on Agitated Behaviour Scale (ABS)', 'timeFrame': 'One year'}, {'measure': 'Functional abilities on the Early Functional Abilities Scale (EFA)', 'timeFrame': 'One year'}, {'measure': 'Functional abilities on the Glasgow Outcome Extend Scale', 'timeFrame': '12 month after admission'}], 'secondaryOutcomes': [{'measure': 'Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury (TBI)', 'Agitated Behaviour']}, 'descriptionModule': {'briefSummary': 'This study examines the effect of an intervention consisting of dynamic circadian light and sound therapy, as well as systematic information on sleep pattern, agitated behavior and functioning level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moderate and severe Traumatic Brain Injury (TBI)\n* Diagnosed with Glasgow Coma Score (GCS) lower than 13-\n\nExclusion Criteria:\n\n* Patients with psychiatric diagnose and not speaking danish -'}, 'identificationModule': {'nctId': 'NCT02524067', 'acronym': 'ABS', 'briefTitle': 'Modified Environment for Agitation in Patients With TBI', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Modified Environment for Agitation in Patients With Traumatic Brain Injury: a Controlled Multicenter', 'orgStudyIdInfo': {'id': 'ABS project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient', 'interventionNames': ['Behavioral: Multifactorial circadian concept']}], 'interventions': [{'name': 'Multifactorial circadian concept', 'type': 'BEHAVIORAL', 'description': 'Circadian light, systematic information, music, individual foreclosure', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Region Midt', 'country': 'Denmark', 'facility': 'Leanne Langhorn', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Jens Christian H Sorensen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hoapital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Regionshospitalet Hammel Neurocenter', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}