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

NCT04327778 | Withdrawn

• 1 other identifier: 18-AOI-09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Major Neurocognitive Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of falls

  At 3 months

• Sleeping troubles

  At 3 months

• Rate of anxiety

  At 3 months

Study Arms (1)

Music therapy

EXPERIMENTAL

Patients will be exposed every two weeks

Procedure: Music Therapy

Interventions

Music Therapy PROCEDURE

Automate music therapy every two weeks

Music therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: August 9, 2021
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FR (1)