- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327778
Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes (MAGE)
April 6, 2020 updated by: Centre Hospitalier Universitaire de Nice
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
Conditions
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
- Name: Hakima LABSI, Project manager
- Phone Number: 0033492034504
- Email: labsi.h@chu-nice.fr
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-AOI-09
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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