Alzheimer Disease or Associated DisorderSweet nightMDCNCT07207642
Sweet Night (Musical Diffusion by Caregivers ): Effects of Musical Diffusion by Caregivers on Sleep Onset and Behavioral Regulation in a Protected Living
An observational study of Alzheimer Disease or Associated Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease or Associated Disorder
- What is being tested?
- Music intervention - passive listening and Audio books intervention - active listening
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2026to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 and over, meeting the diagnostic criteria for Alzheimer's disease and related disorders, living in a Protected Living Unit (PLU) will be included.
Who may be able to join
- 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.
Who cannot join
- Refusal to participate.
- Participation in a study on a drug /medical device / care technique that could affect sleep or behavior during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, France, 42100
Isabelle ROUCH, Md, (0)477127399 ext. +33, isabelle.rouch@chu-st-etienne.fr
Céline BORG, PhD, (0)477127805 ext. +33, celine.borg@chu-st-etienne.fr
About this study
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.
- Conditions
- Alzheimer Disease or Associated Disorder
- Being tested
- Music intervention - passive listening, Audio books intervention - active listening
- Keywords
- Alzheimer's disease, Music intervention, Behavior disorder
- Medical subject headings
- Alzheimer Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music intervention - passive listeningBehavioural
Diffusion of familiar music in the bedrooms and living room before bedtime; passive and individual listening.
Audio books intervention - active listeningBehavioural
Dynamic audio book listening, akin to active listening while respecting the rhythm of the evening . This type of listening involves concentrating specifically .
| Study group | Role | What they receive |
|---|---|---|
| Passive EXPERIMENT | Measurement of the effects of a personalised music listening session at bedtime (play-list) for 10 days. Each patient is his or her own control. Behavioural and actigraphic data are collected and compared before, during and after the intervention. Receives: Behavioral: Music intervention - passive listening | |
| Active EXPERIMENT | An intervention based on listening to audio books, led by a therapist for 10 evenings . Each patient is his or her own control and takes part in the entire experiment. Behavioural and actigraphic data are collected and compared before, during and after intervention. Receives: Behavioral: Audio books intervention - active listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration
Sleep duration will be measured by actigraphy (bracelet worn by the participants).
Measured: Days 1 to 51
Secondary outcomes (4)
Sleep onset and nocturnal awakenings reduction
Sleep onset latency and number of nocturnal awakenings measured by actigraphy.
Measured: Days 1 to 51
Daytime agitation reduction
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.
Measured: Days 1 to 51
Mood improvement
Caregiver questionnaire: category scale : for agitation and mood.
Measured: Days 1 to 51
Falls number reduction
Fall questionnaire include in the caregiver questionnaire.
Measured: Days 1 to 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start13 Jan 2026
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease or Associated DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle ROUCH, Md, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207642
- Sponsor's protocol ID
- 25CH036
- Other IDs
- 2025-A00468-41
- Acronym
- Sweet nightMDC
- Status last verified
- Jan 2026
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweet Night (Musical Diffusion by Caregivers ): Effects of Musical Diffusion by Caregivers on Sleep Onset and Behavioral Regulation in a Protected Living
- ClinicalTrials.gov ID
- NCT07207642
- Acronym / sponsor ID
- Sweet nightMDC / 25CH036
- Conditions
- Alzheimer Disease or Associated Disorder
- Keywords
- Alzheimer's disease, Music intervention, Behavior disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive EXPERIMENT | – | Behavioral: Music intervention - passive listeningMeasurement of the effects of a personalised music listening session at bedtime (play-list) for 10 days. Each patient is his or her own control. Behavioural and actigraphic data are collected and compared before, during and after the intervention. |
| Active EXPERIMENT | – | Behavioral: Audio books intervention - active listeningAn intervention based on listening to audio books, led by a therapist for 10 evenings . Each patient is his or her own control and takes part in the entire experiment. Behavioural and actigraphic data are collected and compared before, during and after intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 and over, meeting the diagnostic criteria for Alzheimer's disease and related disorders, living in a Protected Living Unit (PLU) will be included.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal to participate.
- Participation in a study on a drug /medical device / care technique that could affect sleep or behavior during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music intervention - passive listeningDiffusion of familiar music in the bedrooms and living room before bedtime; passive and individual listening. | Behavioural | Passive EXPERIMENT |
| Audio books intervention - active listeningDynamic audio book listening, akin to active listening while respecting the rhythm of the evening . This type of listening involves concentrating specifically . | Behavioural | Active EXPERIMENT |
Primary outcome
Sleep duration
Time frame: Days 1 to 51
Sleep duration will be measured by actigraphy (bracelet worn by the participants).
4 secondary outcomes
Sleep onset and nocturnal awakenings reduction
Time frame: Days 1 to 51
Daytime agitation reduction
Time frame: Days 1 to 51
Mood improvement
Time frame: Days 1 to 51
Falls number reduction
Time frame: Days 1 to 51
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle ROUCH, Md principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease or Associated Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle ROUCH, Md ((0)477127399 ext. +33, isabelle.rouch@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration (time frame: Days 1 to 51). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.