NCT07465783

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Feb 2026Sep 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

January 21, 2026

Last Update Submit

July 31, 2026

Conditions

Alzheimer Disease or Associated Disorder

Keywords

Alzheimer's diseaseBehavior disorderMusic intervention

Outcome Measures

Primary Outcomes (1)

  • Music

    Changing in sleep duration, following an evening music-based intervention in older adults with Alzheimer's disease or related disorders living in a protected care unit (UVP), assessed by actigraphy

    Baseline (Days 1-10); TEST intervention (Days 11-20); post-intervention follow-up (Days 21-40); CONTROL intervention (Days 41-50); post-control follow-up (Days 51-60). Outcomes assessed throughout all study periods.

Secondary Outcomes (4)

  • sleep parameter (1)

    hroughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up)

  • Daytime disruptive behaviors

    Throughout all study periods (Days 1-60).

  • Falls

    Throughout all study periods (Days 1-60)

  • sleep parameter (2)

    Throughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up)

Study Arms (2)

Test musicale intervention

EXPERIMENTAL

musicale intervention before night

Other: Test musicale intervention

Controle: audio book

ACTIVE COMPARATOR

listenning audio book with an experimenter

Other: Controle: audio book

Interventions

Test musicale interventionOTHER

listenning music

Test musicale intervention
Controle: audio bookOTHER

listenning audio books

Controle: audio book

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-etienne hospital

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseMental Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Officials

  • Isabelle ROUCH, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle ROUCH, MD

CONTACT

(0)477127399isabelle.rouch@chu-st-etienne.fr

Céline BORG, PhD

CONTACT

(0)477127805celine.borg@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

March 12, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 3, 2026

Record last verified: 2026-07

Locations

FR(1)