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NCT Number: NCT07207642

Sweet Night (Musical Diffusion by Caregivers ): Effects of Musical Diffusion by Caregivers on Sleep Onset and Behavioral Regulation in a Protected Living

As the Alzheimer's disease progresses, caregivers and family members often focus on behavioral difficulties. In response to crises, immediate actions tend to favor restraints, either through medication or physical means. This work aims to improve the management of behavioral disturbances in patients with Alzheimer's disease through musical interventions (group or individual), particularly in advanced stages of the disease, where medical and family resources are insufficient. The investigators approach prioritizes NTM over medication as a mean to improve patient well-being. To this end, they have designed a study. The study focuses on creating a conducive environment for sleep by incorporating ritualized, familiar music sessions supervised by nursing staff after meals. To conduct this study, the actigraphy will be used to analyze participants' behavior both day and night, complemented by questionnaires and clinical observations.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Etienne, France, 42100

Location status: Recruiting

Location contact

Céline BORG, PhD

CONTACT

[email protected]

(0)477127805 ext. +33

Céline BORG, PhD

SUB_INVESTIGATOR

Isabelle ROUCH, Md

CONTACT

[email protected]

(0)477127399 ext. +33

Isabelle ROUCH, Md

PRINCIPAL_INVESTIGATOR

Yohana Lévêque, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-opposition of the patient's legal guardian.
  • Patients aged 60 and over, meeting the diagnostic criteria for Alzheimer's disease and related disorders.
  • Patients living in a Protected Living Unit (PLU)
  • If consuming psychotropic medications, they must have been stabilized for 3 months.
  • If consuming level 2 or 3 analgesics, they must have been stabilized for 1 month.

Exclusion criteria

  • Refusal to participate.
  • Participation in a study on a drug /medical device / care technique that could affect sleep or behavior during the study.

Treatment and study plan

Music intervention - passive listening

Behavioral

Diffusion of familiar music in the bedrooms and living room before bedtime; passive and individual listening.

Audio books intervention - active listening

Behavioral

Dynamic audio book listening, akin to active listening while respecting the rhythm of the evening . This type of listening involves concentrating specifically .

Primary outcomes

  1. Sleep duration

    Time frame: Days 1 to 51

    Sleep duration will be measured by actigraphy (bracelet worn by the participants).

Secondary outcomes

  1. Sleep onset and nocturnal awakenings reduction

    Time frame: Days 1 to 51

    Sleep onset latency and number of nocturnal awakenings measured by actigraphy.

  2. Daytime agitation reduction

    Time frame: Days 1 to 51

    Cohen-Mansfield Agitation Inventory score, which assesses 29 items including: non-aggressive physical agitation (1-13), non-aggressive verbal agitation (14-17), physical agitation and aggression (18-26), and verbal agitation and aggression (27-29). A high score reflects intense agitation.

  3. Mood improvement

    Time frame: Days 1 to 51

    Caregiver questionnaire: category scale : for agitation and mood.

  4. Falls number reduction

    Time frame: Days 1 to 51

    Fall questionnaire include in the caregiver questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Céline BORG, PhD

CONTACT

[email protected]

(0)477127805 ext. +33

Isabelle ROUCH, Md

CONTACT

[email protected]

(0)477127399 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: Sweet nightMDC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Oct 6, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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