Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes

NCT ID: NCT04327778

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-08-31

Brief Summary

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Alzheimer disease is the most common neurodegenerative brain disease that causes cognitive impairment in the elderly but also behavioral and psychological symptoms. Among these symptoms, agitation is one of the most dangerous because it put the patient and their caregivers in danger. Sleep disorders can be the cause of many psychiatric symptoms leading directly or indirectly to agitation. Music therapy is the non-drug therapy which has been shown to be the most effective in managing agitation and sleep disorders. With the MAGE protocol, the investigators propose to take care of behavioral disorders in severe Alzheimer patients living in nursing home through sequences of music therapy (stimulation, relaxation) automatically initiated by an actigraph that will detect sleep disorders. These subjects will be exposed for 2 weeks over a month. Behavioral and sleep disorders will be evaluated objectively by actigraphy but also by standardized scales, as the others neuropsychiatric symptoms found classically in this disease. Thanks to this project, the investigators hope to improve the quality of life of these patients by preventing them from putting themselves in danger, by reducing their neuropsychiatric symptoms and their use of medication, which has often deleterious side effect and also by reducing the workload of caregivers.

Detailed Description

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Conditions

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Alzheimer Disease Major Neurocognitive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Music therapy

Patients will be exposed every two weeks

Group Type EXPERIMENTAL

Music Therapy

Intervention Type PROCEDURE

Automate music therapy every two weeks

Interventions

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Music Therapy

Automate music therapy every two weeks

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 60 years old
* Male or Female
* Patients with a diagnosis of Alzheimer disease according to the criteria of NINCDS-ADRDA or typical or atypical Alzheimer disease
* MMSE \< 20
* Patient residing in nursing home
* Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator)
* Affiliation to a social security system

Exclusion Criteria

* Prescription of a new psychotropic treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in week prior to the evaluation
* Hearing loss preventing the patient from responding perfectly to the therapeutic solutions provided
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Central Contacts

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Hakima LABSI, Project manager

Role: CONTACT

0033492034504

Other Identifiers

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18-AOI-09

Identifier Type: -

Identifier Source: org_study_id

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