Alzheimer's DiseaseLACMENCT02670993
Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease
A study testing Singing sessions. and Painting sessions. in people with Alzheimer's Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Singing sessions. and Painting sessions.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2016to Jun 2016
- 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 60 years old and older, fulfilling the diagnostic criteria for Alzheimer's disease to a mild dementia stage, or mild cognitive impairment
- Delay of at least one month between the diagnosis and the early work sessions
- If use of psychotropic drugs, they must be stabilized for 3 month
- If analgesics consumption level 2 or 3 they must be stabilized for 1 month
- With a score greater than or equal to 22 on the simplified visual scale (EVS) pain.
- Visual capabilities , auditory and oral or written expression in French language sufficient for conducting clinical and neuropsychological evaluations;
- MMSE > 20
- Patient affiliated or entitled to a social security scheme
Who cannot join
- Patient with a different etiology of cognitive disorder that of Alzheimer's disease
- Patients with severe disease, progressive or unstable nature which may interfere with the evaluation variables
- Patient with blindness or deafness could compromise its assessment
- Patient under guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices civils de Lyon
Lyon, 69000
Chu Saint Etienne
Saint-Etienne, 42100
About this study
Official title: Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME
Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.
Read the detailed description
Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. At this age, comorbidities are frequent and numerous, and often linked to pain. The prevalence is comprised between 40 and 85% according to different studies. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.
The primary outcome is to evaluate the singing support on physical pain, by comparison with a control activity : "painting session".
- Conditions
- Alzheimer's Disease
- Being tested
- Singing sessions., Painting sessions.
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing sessions.Behavioural
Patients will be in singing work groups, and will participate to these sessions during 12 weeks, with one session per week of 2 hours.
Painting sessions.Behavioural
Patients will be in painting groups, they will participate to this work session during 12 weeks, with one session of 2 hours per week.
| Study group | Role | What they receive |
|---|---|---|
| Control group : Singing sessions. | Experimental | Patients will participate to singing working sessions. They will continue to take their usual treatments during the study period. Receives: Behavioral: Singing sessions. |
| Control group : Painting sessions. | Active comparator | Patients will continue to participate to painting work sessions, and to take their usual treatments during the study. Receives: Behavioral: Painting sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score at the EVS = simplified visual scale
To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity.
Measured: Month 1
Secondary outcomes (2)
Score at the EN (digital scale) scale
To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity.
Measured: Month 1
Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory
To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROUCH Isabelle, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670993
- Sponsor's protocol ID
- 1508071
- Other IDs
- 2015-A01404-45
- Acronym
- LACME
- Status last verified
- Sep 2016
- First submitted
- 25 Jan 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME
- ClinicalTrials.gov ID
- NCT02670993
- Acronym / sponsor ID
- LACME / 1508071
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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.
Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.
Detailed description
Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. At this age, comorbidities are frequent and numerous, and often linked to pain. The prevalence is comprised between 40 and 85% according to different studies. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.
The primary outcome is to evaluate the singing support on physical pain, by comparison with a control activity : "painting session".
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group : Singing sessions. | Experimental | Behavioral: Singing sessions.Patients will participate to singing working sessions. They will continue to take their usual treatments during the study period. |
| Control group : Painting sessions. | Active comparator | Behavioral: Painting sessions.Patients will continue to participate to painting work sessions, and to take their usual treatments during the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients 60 years old and older, fulfilling the diagnostic criteria for Alzheimer's disease to a mild dementia stage, or mild cognitive impairment
- Delay of at least one month between the diagnosis and the early work sessions
- If use of psychotropic drugs, they must be stabilized for 3 month
- If analgesics consumption level 2 or 3 they must be stabilized for 1 month
- With a score greater than or equal to 22 on the simplified visual scale (EVS) pain.
Key exclusion criteria (4 listed)
- Patient with a different etiology of cognitive disorder that of Alzheimer's disease
- Patients with severe disease, progressive or unstable nature which may interfere with the evaluation variables
- Patient with blindness or deafness could compromise its assessment
- Patient under guardianship
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 |
|---|---|---|
| Singing sessions.Patients will be in singing work groups, and will participate to these sessions during 12 weeks, with one session per week of 2 hours. | Behavioural | Control group : Singing sessions. |
| Painting sessions.Patients will be in painting groups, they will participate to this work session during 12 weeks, with one session of 2 hours per week. | Behavioural | Control group : Painting sessions. |
Primary outcome
Score at the EVS = simplified visual scale
Time frame: Month 1
To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity.
2 secondary outcomes
Score at the EN (digital scale) scale
Time frame: Month 1
Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- 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. This study is not recruiting at the moment.
ROUCH Isabelle, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing sessions. and Painting sessions. in people with Alzheimer's Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score at the EVS = simplified visual scale (time frame: Month 1). 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 20 Sep 2016.