Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-03 @ 10:06 PM
Study NCT ID:
NCT04702594
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2021-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Therapy and Psycho-behavioral Disorders in the Elderly Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-08-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of the NeuroPsychiatric Inventory (NPI) scale', 'timeFrame': "Baseline, once a week during study participation and at the end of the patient's participation in the study (1 month after inclusion)", 'description': 'The improvement in psycho-behavioral symptoms will be assessed by the NPI score provided by the MUSIC CARE application carried out by a caregiver.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavioral Disorder', 'Music Therapy']}, 'descriptionModule': {'briefSummary': 'Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior\'s aspects ". Music has shown that memory capacity can remain present in people with Alzheimer\'s disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer\'s or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions.\n\nHowever, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 60 present in the reinforced hospital unit during the study period\n* Patients over 60 years hospitalized in follow-up care and rehabilitation with behavioral disorders in the context of a neurocognitive disorder\n\nExclusion Criteria:\n\n* Unpaired deafness\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04702594', 'acronym': 'DEMUse', 'briefTitle': 'Music Therapy and Psycho-behavioral Disorders in the Elderly Population', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of Music Therapy on Psycho-behavioral Disorders of the Elderly Suffering From Neuro-cognitive Disorders', 'orgStudyIdInfo': {'id': '69HCL20_0489'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UHR and SRH', 'description': 'All patients over the age of 60 present in the UHR and hospitalized in SRH with behavioral disorders in the context of a neurocognitive disorder', 'interventionNames': ['Behavioral: Music therapy session via tools validated by MUSIC CARE']}], 'interventions': [{'name': 'Music therapy session via tools validated by MUSIC CARE', 'type': 'BEHAVIORAL', 'description': 'Use of the MUSICARE tool, a digital space allowing access to different validated methods of music therapy. Music listening times are offered to patients with cognitive impairment with psycho-behavioral symptoms. The sessions are individual or group performed by a psychomotor therapist in UHR and volunteer caregivers trained in SRH. The sessions last on average 20-30min.', 'armGroupLabels': ['UHR and SRH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69005', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne FRELY,, PH', 'role': 'CONTACT', 'email': 'anne.frely@chu-lyon.fr', 'phone': '04.72.16.71.41'}], 'facility': 'Hôpital Pierre Garraud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Anne FRELY, MD', 'role': 'CONTACT', 'email': 'anne.frely@chu-lyon.fr', 'phone': '04.72.16.71.41'}, {'name': 'Blandine DE-LA-GASTINE, MD', 'role': 'CONTACT', 'email': 'blandine.de-la-gastine@chu-lyon.fr', 'phone': '04.72.16.71.14'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}