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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04327778
Acronym
MAGE
Enrollment
0
Registered
2020-03-31
Start date
2021-08-09
Completion date
2021-08-09
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Major Neurocognitive Disorder

Brief summary

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.

Interventions

PROCEDUREMusic Therapy

Automate music therapy every two weeks

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neuropsychiatric tests scoresAt 3 monthsNeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120
Nightly agitationAt 3 monthThe number of movements of the patient by the actigraphy, before exposure and at the end of each exposure

Secondary

MeasureTime frameDescription
Number of fallsAt 3 monthsNumber of falls by actigraphy
Sleeping troublesAt 3 monthsHours of sleep by actigraphy
Rate of anxietyAt 3 monthsAnxiety rate measured by taking anxiolytic drugs

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026