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

Study Overview
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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.

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

Conditions
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Alzheimer Disease, Major Neurocognitive Disorder

Intervention / Treatment
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* Procedure: Music Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music therapy<br>Patients will be exposed every two weeks | Procedure: Music Therapy<br>* Automate music therapy every two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric tests scores | NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120 | At 3 months | 
| Nightly agitation | The number of movements of the patient by the actigraphy, before exposure and at the end of each exposure | At 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of falls | Number of falls by actigraphy | At 3 months | 
| Sleeping troubles | Hours of sleep by actigraphy | At 3 months | 
| Rate of anxiety | Anxiety rate measured by taking anxiolytic drugs | At 3 months |