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Clinical Trials/NCT04327778
NCT04327778
Unknown
N/A

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

Centre Hospitalier Universitaire de Nice1 site in 1 country20 target enrollmentApril 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
20
Locations
1
Primary Endpoint
Neuropsychiatric tests scores
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2020
End Date
August 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Neuropsychiatric tests scores

Time Frame: At 3 months

NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120

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

Secondary Outcomes

  • Rate of anxiety(At 3 months)
  • Sleeping troubles(At 3 months)
  • Number of falls(At 3 months)

Study Sites (1)

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