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

Alzheimer Disease Clinical Trial

— MAGE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04327778
• Other study ID #: 18-AOI-09
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: August 2021

Study information

• Verified date: April 2020
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Hakima LABSI, Project manager
• Phone: 0033492034504
• Email: labsi.h[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Major Neurocognitive Disorder
• Neurocognitive Disorders
• Problem Behavior

Intervention

Procedure:
• Music Therapy
Automate music therapy every two weeks

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychiatric tests scores	NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120	At 3 months
Primary	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	Number of falls	Number of falls by actigraphy	At 3 months
Secondary	Sleeping troubles	Hours of sleep by actigraphy	At 3 months
Secondary	Rate of anxiety	Anxiety rate measured by taking anxiolytic drugs	At 3 months