Effects of Musical Intervention by a Therapist (IMT) on Falling Asleep and Behavioral Regulation in a Secure Care Unit (SCU)
Recruiting · NCT07465783 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
View the official record on ClinicalTrials.gov →Interventions studied
Controle: audio bookTest musicale intervention
What this trial is about
This is a prospective, multicenter study designed to evaluate the benefits of an evening music-based intervention on sundowning syndrome in patients with Alzheimer's disease or related disorders in a Protect lLife Unit setting.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Signature of consent by the patient's legal guardian obtained after providing information
- Patients aged 60 and over who meet the diagnostic criteria for Alzheimer's disease and related disorders, including mainly: Lewy body disease, frontotemporal lobar degeneration, progressive supranuclear palsy, corticobasal degeneration, vascular encephalopathy, alcoholic dementia, primary progressive aphasia syndrome, posterior cortical atrophy syndrome (France Alzheimer, 2024).
- Patient living in a secure care unit
- If taking psychotropic drugs, they must have been stable for 3 months
- If taking level 2 or 3 painkillers, they must have been stable for 1 month
Exclusion criteria
- Refusal to participate
- Participation in a study on a drug/medical device/treatment technique that may affect sleep or behavior.
- Highly sedated patients,
- Patients with acute medical instability,
- Patients with productive delusions,
- Patients who have been in the unit for less than 1 month
Where it is running
1 location listed.
- Saint-etienne hospital - Saint-Etienne, France