ClinicalTrials.Veeva

Menu

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

C

Centre Hospitalier Universitaire de Nice

Status

Unknown

Conditions

Major Neurocognitive Disorder
Alzheimer Disease

Treatments

Procedure: Music Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04327778
18-AOI-09

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Music therapy
Experimental group
Description:
Patients will be exposed every two weeks
Treatment:
Procedure: Music Therapy

Trial contacts and locations

1

Loading...

Central trial contact

Hakima LABSI, Project manager

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems