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

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Nice, France
        • CHU de Nice
        • Principal Investigator:
          • Renaud DAVID, PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music therapy
Patients will be exposed every two weeks
Automate music therapy every two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric tests scores
Time Frame: At 3 months
NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120
At 3 months
Nightly agitation
Time Frame: At 3 month
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
Time Frame: At 3 months
Number of falls by actigraphy
At 3 months
Sleeping troubles
Time Frame: At 3 months
Hours of sleep by actigraphy
At 3 months
Rate of anxiety
Time Frame: At 3 months
Anxiety rate measured by taking anxiolytic drugs
At 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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