Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes (NCT04327778) | Clinical Trial Compass
WithdrawnNot Applicable
Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes
Stopped: Impossible d'inclure un premier patient
0Started 2021-08-09
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was withdrawn before enrolling anyone — do you know why it was pulled, and does that affect whether music therapy is still considered a viable option for managing my loved one's behavioral symptoms?
2Since this study was specifically looking at neuropsychiatric symptoms and nightly agitation in nursing home residents with Alzheimer's or major neurocognitive disorder, are there other active trials or established programs studying music therapy for these same issues that we could explore instead?
3Because this trial never reached the point of collecting data, what does the existing evidence actually tell us about whether automated or structured music therapy can help reduce agitation in someone at this stage of the condition?
4Given that behavioral symptoms like nighttime agitation can be really disruptive and distressing, what treatment options — whether non-drug approaches like music therapy or medications — would you recommend we consider right now while we look into research opportunities?
5Are there nursing home or memory care programs in our area that already use music therapy as part of routine care, so my loved one could potentially benefit from this kind of approach without waiting for a clinical trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.