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

Not Applicable

• Conditions: Major Neurocognitive Disorder; Alzheimer Disease
• Interventions: Procedure: Music Therapy

• Registration Number: NCT04327778
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-31
• Status Verified: 2020-04
• Study Start: 2020-04
• Primary Completion: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-07
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Music therapy	Music Therapy	Patients will be exposed every two weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sleeping troubles	At 3 months	Hours of sleep by actigraphy
Number of falls	At 3 months	Number of falls by actigraphy
Rate of anxiety	At 3 months	Anxiety rate measured by taking anxiolytic drugs

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France