Behavioral DisorderDEMUseNCT04702594
Music Therapy and Psycho-behavioral Disorders in the Elderly Population
A study testing Music therapy session via tools validated by MUSIC CARE in people with Behavioral Disorder and Music Therapy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Behavioral Disorder, Music Therapy
- What is being tested?
- Music therapy session via tools validated by MUSIC CARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2021to 18 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients over the age of 60 present in the reinforced hospital unit during the study period
- Patients over 60 years hospitalized in follow-up care and rehabilitation with behavioral disorders in the context of a neurocognitive disorder
Who cannot join
- Unpaired deafness
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Pierre Garraud
Lyon, 69005
Anne FRELY,, PH, 04.72.16.71.41, anne.frely@chu-lyon.fr
About this study
Official title: Impact of Music Therapy on Psycho-behavioral Disorders of the Elderly Suffering From Neuro-cognitive Disorders
Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior's aspects ". Music has shown that memory capacity can remain present in people with Alzheimer's disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer's or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions.
However, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.
- Conditions
- Behavioral Disorder, Music Therapy
- Being tested
- Music therapy session via tools validated by MUSIC CARE
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy session via tools validated by MUSIC CAREBehavioural
Use of the MUSICARE tool, a digital space allowing access to different validated methods of music therapy. Music listening times are offered to patients with cognitive impairment with psycho-behavioral symptoms. The sessions are individual or group performed by a psychomotor therapist in UHR and volunteer caregivers trained in SRH. The sessions last on average 20-30min.
| Study group | Role | What they receive |
|---|---|---|
| UHR and SRH | Experimental | All patients over the age of 60 present in the UHR and hospitalized in SRH with behavioral disorders in the context of a neurocognitive disorder Receives: Behavioral: Music therapy session via tools validated by MUSIC CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the NeuroPsychiatric Inventory (NPI) scale
The improvement in psycho-behavioral symptoms will be assessed by the NPI score provided by the MUSIC CARE application carried out by a caregiver.
Measured: Baseline, once a week during study participation and at the end of the patient's participation in the study (1 month after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start18 Jan 2021
- Primary completion18 Aug 2021 (estimated)
- Study completion18 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702594
- Sponsor's protocol ID
- 69HCL20_0489
- Acronym
- DEMUse
- Status last verified
- Jul 2021
- First submitted
- 7 Jan 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Music Therapy on Psycho-behavioral Disorders of the Elderly Suffering From Neuro-cognitive Disorders
- ClinicalTrials.gov ID
- NCT04702594
- Acronym / sponsor ID
- DEMUse / 69HCL20_0489
- Conditions
- Behavioral Disorder, Music Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 18 Aug 2021 (estimated)
- Study completion
- 18 Aug 2021 (estimated)
- First posted
- 11 Jan 2021 (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.
Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior's aspects ". Music has shown that memory capacity can remain present in people with Alzheimer's disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer's or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions.
However, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UHR and SRH | Experimental | Behavioral: Music therapy session via tools validated by MUSIC CAREAll patients over the age of 60 present in the UHR and hospitalized in SRH with behavioral disorders in the context of a neurocognitive disorder |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 60 present in the reinforced hospital unit during the study period
- Patients over 60 years hospitalized in follow-up care and rehabilitation with behavioral disorders in the context of a neurocognitive disorder
Key exclusion criteria (2 listed)
- Unpaired deafness
- Refusal to participate
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 therapy session via tools validated by MUSIC CAREUse of the MUSICARE tool, a digital space allowing access to different validated methods of music therapy. Music listening times are offered to patients with cognitive impairment with psycho-behavioral symptoms. The sessions are individual or group performed by a psychomotor therapist in UHR and volunteer caregivers trained in SRH. The sessions last on average 20-30min. | Behavioural | UHR and SRH |
Primary outcome
Evolution of the NeuroPsychiatric Inventory (NPI) scale
Time frame: Baseline, once a week during study participation and at the end of the patient's participation in the study (1 month after inclusion)
The improvement in psycho-behavioral symptoms will be assessed by the NPI score provided by the MUSIC CARE application carried out by a caregiver.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy session via tools validated by MUSIC CARE in people with Behavioral Disorder and Music Therapy, run by Hospices Civils de Lyon 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 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne FRELY, MD (04.72.16.71.41, anne.frely@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the NeuroPsychiatric Inventory (NPI) scale (time frame: Baseline, once a week during study participation and at the end of the patient's participation in the study (1 month after inclusion)). 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 14 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.