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

Primary Purpose

Alzheimer Disease, Major Neurocognitive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Music therapy

Arm Description

Patients will be exposed every two weeks

Outcomes

Primary Outcome Measures

Neuropsychiatric tests scores
NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120
Nightly agitation
The number of movements of the patient by the actigraphy, before exposure and at the end of each exposure

Secondary Outcome Measures

Number of falls
Number of falls by actigraphy
Sleeping troubles
Hours of sleep by actigraphy
Rate of anxiety
Anxiety rate measured by taking anxiolytic drugs

Full Information

First Posted
March 27, 2020
Last Updated
April 6, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04327778
Brief Title
Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes
Acronym
MAGE
Official Title
Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Major Neurocognitive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music therapy
Arm Type
Experimental
Arm Description
Patients will be exposed every two weeks
Intervention Type
Procedure
Intervention Name(s)
Music Therapy
Intervention Description
Automate music therapy every two weeks
Primary Outcome Measure Information:
Title
Neuropsychiatric tests scores
Description
NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120
Time Frame
At 3 months
Title
Nightly agitation
Description
The number of movements of the patient by the actigraphy, before exposure and at the end of each exposure
Time Frame
At 3 month
Secondary Outcome Measure Information:
Title
Number of falls
Description
Number of falls by actigraphy
Time Frame
At 3 months
Title
Sleeping troubles
Description
Hours of sleep by actigraphy
Time Frame
At 3 months
Title
Rate of anxiety
Description
Anxiety rate measured by taking anxiolytic drugs
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hakima LABSI, Project manager
Phone
0033492034504
Email
labsi.h@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud David, PH

12. IPD Sharing Statement

Learn more about this trial

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

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