Neurodegenerative DiseasesARPENCT07748013
Impact of Harp Therapy on Behavioral Disorders in Nursing Home Residents With Neurodegenerative Disease (ARPE)
An observational study of Neurodegenerative Diseases and Behavioral Symptoms, run by LNA SANTE at 1 site in France.
Trial summary
The ARPE study looked at whether weekly harp therapy sessions could reduce behavioral problems in older adults living in memory care units of a nursing home (EHPAD). These residents had moderate-to-severe neurodegenerative diseases (such as Alzheimer's disease or related conditions) and displayed disruptive behaviors… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurodegenerative Diseases, Behavioral Symptoms, Dementia
- What is being tested?
- Harp therapy (receptive music therapy)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to 31 Mar 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All eligible residents from the two memory care units of Villa Éléonore, a nursing home operated by LNA Santé in France.
Who may be able to join
- Living permanently in a memory care unit (unité protégée) of Villa Éléonore nursing home for at least 2 months
- Diagnosed with a moderate-to-severe neurodegenerative disease (such as Alzheimer's disease or a related condition), AND/OR Mini-Mental State Examination (MMSE) score of 15 or below (or MMSE not evaluable), assessed within the last 12 months
- Presenting moderate-to-severe disruptive behavioral difficulties, such as anxiety, agitation, nighttime wandering, or difficulty falling asleep
- Participant and/or their legal representative has been informed about the study and has not objected to the use of their pseudonymized data
Who cannot join
- Unstabilized psychiatric condition
- Uncorrected hearing impairment causing sensory isolation (i.e., without appropriate hearing aids)
- Documented end-of-life status in the medical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Receptive Music Therapy Via Harp on Neuropsychiatric Symptoms in Nursing Home Residents With Moderate-to-Severe Neurodegenerative Disease Living in Memory Care Units: A Prospective Single-Center Observational Study
The ARPE study looked at whether weekly harp therapy sessions could reduce behavioral problems in older adults living in memory care units of a nursing home (EHPAD). These residents had moderate-to-severe neurodegenerative diseases (such as Alzheimer's disease or related conditions) and displayed disruptive behaviors, especially in the late afternoon and evening.
Harp therapy (harpe-thérapie) is a form of receptive music therapy. During each session, a trained harp therapist plays music live for participants. Unlike other music therapy approaches, residents simply listen - they do not need to move, sing, or play an instrument. Receptive music therapy uses sound to promote relaxation, reduce anxiety, and stimulate memory and emotions.
Read more
The main questions this study aimed to answer were:
Can weekly harp therapy sessions reduce neuropsychiatric symptoms (such as agitation, anxiety, and sleep disturbances) in residents with neurodegenerative diseases? Does harp therapy reduce the use of psychotropic medications (sleeping pills, antidepressants, antipsychotics)? Does harp therapy improve residents' well-being immediately before and after each session? Does harp therapy improve the well-being of care staff and help them manage residents' behavioral difficulties?
What participants did:
Took part in one collective harp therapy session per week in the late afternoon for 12 weeks Were evaluated for behavioral symptoms at the start of the study, at week 6, at week 12, and 3 months after the last session Were assessed for immediate well-being before and after each session Care staff were asked to rate their own well-being twice a week (once after a harp therapy session, once on a day without a session)
The study took place at Villa Éléonore, a single nursing home run by LNA Santé in France, and included all eligible residents from two memory care units.
Read the detailed description
- Background and Rationale Non-pharmacological interventions (NPIs) are non-invasive, non-pharmacological care techniques designed to prevent, manage, or alleviate certain conditions as complementary approaches to standard treatments. NPIs are central to LNA Santé's SENS care approach, with the objective of integrating them systematically into the management of neurodegenerative disorders associated with behavioral disturbances, in line with French health authority recommendations. Among these interventions, music therapy is one of the most evidence-supported. Its efficacy has been demonstrated for apathy , anxiety and depression , cognitive and emotional functioning, and pain management. Two approaches exist: active music therapy (participants produce music) and receptive music therapy (participants listen to music), which can be combined.
- Rationale for the Intervention Harp therapy (harpe-thérapie) is a form of receptive music therapy in which a trained therapist plays the harp live during individual or group sessions. Villa Éléonore first introduced harp therapy in late 2023 through a trainee from the first French cohort of harp therapy practitioners. Initial individual sessions with apathetic, bedridden, or palliative residents produced moments of emotional soothing and arousal and were positively received by families. Subsequent group sessions in memory care units in the late afternoon contributed to a general calming effect during and after the session, including a smoother dinner transition and a more serene bedtime routine. Given these positive preliminary observations and the absence of published literature on harp therapy specifically, Villa Éléonore designed the ARPE study to objectively measure the impact of structured harp therapy sessions on behavioral symptoms in memory care residents. The working hypothesis was that harp therapy would reduce disruptive behavioral symptoms (particularly sundowning-related agitation, verbal and non-verbal aggression, and sleep disturbance), reduce psychotropic medication use, and improve staff well-being.
- Study Design ARPE is a prospective, single-center, single-group observational study. No control group or comparator was included. All eligible residents from both memory care units of Villa Éléonore were offered participation. The study followed a longitudinal repeated-measures design over 6 months, including 12 weeks of weekly harp therapy sessions and a 3-month post-intervention follow-up. Regulatory classification: This study is classified as Research Not Involving the Human Person (Recherche N'Impliquant pas la Personne Humaine - RNIPH) under Article L1121-1 of the French Public Health Code, as it does not pursue biological or medical knowledge objectives involving experimental procedures. Data collection is governed by French data protection standards under CNIL Reference Methodology MR-004, which ensures pseudonymization.
- Intervention Description Harp Therapy (Receptive Music Therapy) A certified harp therapist delivers one live group harp therapy session per week for 12 consecutive weeks to all participating residents simultaneously in their memory care unit. Sessions take place in the late afternoon (approximately 5:00-6:30 PM), a period associated with increased behavioral disturbances (sundowning syndrome). Residents are seated comfortably and listen to the harp music live. No active participation (playing, singing, or moving) is required. Session duration is not specified in the protocol but is consistent with standard harp therapy practice (approximately 30-45 minutes). Residents who do not wish to attend on a given week may decline.
- Standard of Care All participants continue to receive their usual nursing home care, including ongoing pharmacological treatments and other NPIs (e.g., physiotherapy, occupational therapy). These are documented at each study visit to assess their potential influence on behavioral outcomes.
- Visit Schedule and Procedures Visit Timing Assessments Pre-inclusion (V-S) Day -10 Study presentation to residents and families; information letter distributed; 10-day non-opposition reflection period Inclusion (V0) Day 0 Non-opposition documented; NPI-ES, CMAI; demographics, clinical data, MMSE, GIR, psychotropic medications (past 6 weeks), other NPIs During 12 sessions Weekly (W1-W12) EVIBE (before and after each session); LIKERT staff well-being (twice/week - once post-session, once on a session-free day) Intermediate visit (V6) Week 6 NPI-ES, CMAI; psychotropic medications and other NPIs (past 6 weeks) End-of-session visit (V12) Week 12 NPI-ES, CMAI; psychotropic medications and other NPIs (past 6 weeks) End-of-study assessment 3 months after last session NPI-ES, CMAI; psychotropic medications and other NPIs (past 3 months)
- Assessment Tools NPI-ES (Neuropsychiatric Inventory - Caregiver Version) The NPI-ES is a validated, structured caregiver-administered interview assessing 12 neuropsychiatric symptom domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders, and appetite/eating abnormalities. Each domain is rated on frequency (1-4) and severity (1-3); domain score = frequency × severity (0-12). Total score ranges from 0 to 144; higher scores indicate greater neuropsychiatric symptom burden. CMAI (Cohen-Mansfield Agitation Inventory) The CMAI is a validated 29-item tool assessing the frequency of agitated behaviors in nursing home residents. Each item is rated on a 7-point scale (1 = never, 7 = several times per hour). Total score ranges from 29 to 203; higher scores indicate greater agitation. EVIBE (Évaluation Immédiate du Bien-Être) The EVIBE is a brief, standardized immediate well-being assessment tool used in French geriatric and psychogeriatric settings. It is administered by a trained clinician (psychologist, occupational therapist, or psychomotor therapist) before and after each harp therapy session to capture immediate changes in residents' perceived well-being. It uses a visual or ordinal scale to quantify well-being. A higher score indicates better well-being. LIKERT Staff Well-Being Scale A Likert-type scale completed by voluntary care staff members to rate their own immediate well-being and their perceived ease of managing residents' behavioral difficulties. Administered twice per week: once after a harp therapy session, and once on a day without a session, to capture potential carry-over effects on staff experience. Score ranges from 1 to 5 (or 1 to 7 depending on the version used); higher scores indicate better well-being / greater ease of managing behavior.
- Statistical Analysis Plan Statistical analyses were conducted by the LNA Santé research support unit using R (version 3.6.1). Given the exploratory nature of the study and the absence of a comparator arm, no formal sample size calculation was performed; enrollment was driven by the estimated inclusion capacity of Villa Éléonore (25-30 residents). No interim analysis was planned. Descriptive statistics: Quantitative variables are described by number of observations, mean, standard deviation, minimum, maximum, 25th/50th/75th percentiles, and 95% bilateral confidence intervals. Qualitative variables are described by frequency counts and relative/absolute percentages. Inferential statistics: Comparisons across the four time points are performed using one-way analysis of variance (ANOVA) for quantitative variables and chi-squared tests for qualitative variables. All tests are bilateral with an overall alpha risk of 5%. A p-value < 0.05 is considered statistically significant. All confidence intervals are 95% bilateral.
- Benefit-Risk Assessment Expected benefits: Reduction in neuropsychiatric symptoms (particularly sundowning-related agitation, verbal/non-verbal aggression, anxiety, sleep disturbances, aberrant motor behavior); reduction in psychotropic medication use; improvement in residents' and care staff's well-being. Identified risks: Paradoxical anxiety reactions; emotional activation (reactivation of distress linked to past trauma or memories); auditory discomfort. All risks are considered minimal. Any adverse reaction may lead to withdrawal from the study at the investigator's discretion.X
- Regulatory and Ethical Framework This study is classified as RNIPH under French law (Article L1121-1 of the Public Health Code) and does not require review by a Committee for the Protection of Persons (CPP). Data collection and processing comply with CNIL Reference Methodology MR-004, pursuant to the French Data Protection Act (Law No. 78-17 of 6 January 1978, as amended). A 10-day non-opposition period was offered to all residents and/or their legal representatives before inclusion. The sponsor (LNA Santé) is the data controller. Data are pseudonymized; the correspondence list is held exclusively by the coordinating investigator. Results will be compiled into an internal report for LNA Santé establishments. No external publication is planned.
- Conditions
- Neurodegenerative Diseases, Behavioral Symptoms, Dementia, Agitation
- Being tested
- Harp therapy (receptive music therapy)
- Keywords
- Harp therapy, Music therapy, Neurodegenerative diseases, Neuropsychiatric symptoms, Behavioral and psychological symptoms of dementia, Agitation, Anxiety, Non-pharmacological intervention, Nursing home
- Medical subject headings
- Neurodegenerative Diseases, Behavioral Symptoms, Dementia, Psychomotor Agitation, Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harp therapy (receptive music therapy)Behavioural
arp therapy is a form of receptive music therapy in which a certified harp therapist plays the harp live during group sessions. Participants passively listen to live harp music without any required physical, vocal, or instrumental participation. The acoustic and vibrational properties of the harp are used to promote relaxation, reduce anxiety, and stimulate emotional and memory processes in people with neurodegenerative diseases.
In this study, one group session was delivered weekly in the late afternoon (sundowning period) in the memory care unit, for 12 consecutive weeks. Each session lasted approximately 30 to 45 minutes. All eligible residents from both memory care units attended collectively. Harp therapy was provided as part of the facility's non-pharmacological care program and observed prospectively; participants were not assigned to this intervention by the research team.
| Study group | Role | What they receive |
|---|---|---|
| Harp Therapy Cohort | Nursing home residents living in one of the two memory care units (unités protégées) of Villa Éléonore (LNA Santé, France), diagnosed with moderate-to-severe neurodegenerative disease (e.g., Alzheimer's disease or related conditions) and presenting moderate-to-severe disruptive behavioral disorders (agitation, anxiety, sleep disturbances), who received one weekly group live harp therapy session in the late afternoon for 12 consecutive weeks. All eligible residents from both units were offered participation (non-probability, consecutive sampling). Behavioral symptoms, psychotropic medication use, and well-being were assessed at baseline, week 6, week 12, and 3 months after the last session. Receives: Behavioral: Harp therapy (receptive music therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Neuropsychiatric Symptoms as Assessed by the Neuropsychiatric Inventory - Caregiver Version (NPI-ES) at Week 6, Week 12, and Month 15
The NPI-ES (Neuropsychiatric Inventory - Échelle pour les Soignants) is a validated, structured caregiver-administered interview assessing 12 neuropsychiatric domains: delusions, hallucinations, agitation/aggression, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, sleep disorders, and appetite changes. Each domain is rated by frequency (1-4) and severity (1-3); domain score = frequency × severity. Total score ranges from 0 to 144; higher score = greater neuropsychiatric symptom burden. Minimum clinically important difference (MCID): not formally established for this population in a single-arm design.
Measured: Baseline (Day 0), Week 6 (after the 6th session), Week 12 (after the 12th session), and Month 15 (3 months after the last session)
Secondary outcomes (8)
Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Week 6
The CMAI is a validated 29-item scale rating the frequency of agitated behaviors over the preceding 2 weeks. Items include physically non-aggressive behaviors (e.g., pacing, restlessness), physically aggressive behaviors (e.g., hitting, kicking), and verbally agitated behaviors (e.g., screaming, complaining). Each item is rated 1-7 (1 = never; 7 = several times per hour). Total score ranges from 29 to 203; higher score = greater agitation. Completed by trained care staff.
Measured: Baseline (Day 0) and Week 6 (after the 6th harp therapy session)
Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Week 12
Same as Outcome 2. Total score ranges from 29 to 203; higher score = greater agitation.
Measured: Baseline (Day 0) and Week 12 (after the 12th harp therapy session)
Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Month 15
Same as Outcome 2. Total score ranges from 29 to 203; higher score = greater agitation.
Measured: Baseline (Day 0) and Month 15 (3 months after the last harp therapy session)
Change from Baseline in Psychotropic Medication Use at Week 6
Documentation of the number and type of psychotropic medications prescribed (both maintenance and as-needed) in the 6 weeks preceding each assessment point: benzodiazepines, antidepressants, antipsychotics (neuroleptics), and hypnotics. Data are extracted from the electronic medical record (Netsoins). Reported as number of active prescriptions and/or defined daily doses per class.
Measured: Baseline (6 weeks preceding Day 0) and Week 6 (6 weeks preceding the Week 6 visit)
Change from Baseline in Psychotropic Medication Use at Week 12
Same as Outcome 5. Data extracted from electronic medical record for the 6 weeks preceding the Week 12 assessment.
Measured: Baseline (6 weeks preceding Day 0) and Week 12 (6 weeks preceding the Week 12 visit)
Change from Baseline in Psychotropic Medication Use at Month 15
Same as Outcome 5. Data extracted from electronic medical record for the 3 months preceding the end-of-study assessment.
Measured: Baseline (6 weeks preceding Day 0) and Month 15 (3 months preceding the end-of-study visit)
Change in Immediate Resident Well-Being Before and After Each Harp Therapy Session as Assessed by the EVIBE Scale
The EVIBE (Évaluation Immédiate du Bien-Être) is a brief, standardized well-being assessment tool administered by a trained clinician (psychologist, occupational therapist, or psychomotor therapist) before and after each harp therapy session. It captures immediate variations in perceived well-being using a visual or ordinal scale. Higher score = better well-being. Within-session change (post-session minus pre-session) is the key indicator. Administered at each of the 12 weekly sessions.
Measured: Before and after each weekly harp therapy session, from Week 1 to Week 12 (12 assessments over 12 weeks)
Care Staff Well-Being and Perceived Ease of Managing Behavioral Disorders as Assessed by a Likert Scale
Volunteer care staff members rate their own immediate well-being and their perceived ease of managing residents' behavioral disturbances using a Likert-type scale (range typically 1-5 or 1-7; higher score = better well-being / greater perceived ease). The scale is completed twice per week throughout the 12-week intervention period: once following a harp therapy session, and once on a day without a session, enabling within-subject comparison of staff experience across session and non-session days.
Measured: Twice weekly throughout the 12-week harp therapy period (Weeks 1-12), approximately 24 assessments per staff member
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Oct 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- LNA SANTE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine POINTEREAU, Principal investigator, Villa Eléonore - LNA SANTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748013
- Sponsor's protocol ID
- ARPE
- Acronym
- ARPE
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Results of this study will be disseminated through publication in a peer-reviewed scientific journal. Data are governed by the French data protection framework (CNIL Reference Methodology MR-004), which prohibits sharing of pseudonymized individual-level data outside the study framework. The small sample size (25-30 participants) also presents a re-identification risk that precludes IPD sharing.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Receptive Music Therapy Via Harp on Neuropsychiatric Symptoms in Nursing Home Residents With Moderate-to-Severe Neurodegenerative Disease Living in Memory Care Units: A Prospective Single-Center Observational Study
- ClinicalTrials.gov ID
- NCT07748013
- Acronym / sponsor ID
- ARPE / ARPE
- Conditions
- Neurodegenerative Diseases, Behavioral Symptoms, Dementia, Agitation
- Keywords
- Harp therapy, Music therapy, Neurodegenerative diseases, Neuropsychiatric symptoms, Behavioral and psychological symptoms of dementia, Agitation, Anxiety, Non-pharmacological intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- LNA SANTEUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 5 Aug 2026 (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.
The ARPE study looked at whether weekly harp therapy sessions could reduce behavioral problems in older adults living in memory care units of a nursing home (EHPAD). These residents had moderate-to-severe neurodegenerative diseases (such as Alzheimer's disease or related conditions) and displayed disruptive behaviors, especially in the late afternoon and evening.
Harp therapy (harpe-thérapie) is a form of receptive music therapy. During each session, a trained harp therapist plays music live for participants. Unlike other music therapy approaches, residents simply listen - they do not need to move, sing, or play an instrument. Receptive music therapy uses sound to promote relaxation, reduce anxiety, and stimulate memory and emotions.
The main questions this study aimed to answer were:
Can weekly harp therapy sessions reduce neuropsychiatric symptoms (such as agitation, anxiety, and sleep disturbances) in residents with neurodegenerative diseases? Does harp therapy reduce the use of psychotropic medications (sleeping pills, antidepressants, antipsychotics)? Does harp therapy improve residents' well-being immediately before and after each session? Does harp therapy improve the well-being of care staff and help them manage residents' behavioral difficulties?
What participants did:
Took part in one collective harp therapy session per week in the late afternoon for 12 weeks Were evaluated for behavioral symptoms at the start of the study, at week 6, at week 12, and 3 months after the last session Were assessed for immediate well-being before and after each session Care staff were asked to rate their own well-being twice a week (once after a harp therapy session, once on a day without a session)
The study took place at Villa Éléonore, a single nursing home run by LNA Santé in France, and included all eligible residents from two memory care units.
Detailed description
- Background and Rationale Non-pharmacological interventions (NPIs) are non-invasive, non-pharmacological care techniques designed to prevent, manage, or alleviate certain conditions as complementary approaches to standard treatments. NPIs are central to LNA Santé's SENS care approach, with the objective of integrating them systematically into the management of neurodegenerative disorders associated with behavioral disturbances, in line with French health authority recommendations. Among these interventions, music therapy is one of the most evidence-supported. Its efficacy has been demonstrated for apathy , anxiety and depression , cognitive and emotional functioning, and pain management. Two approaches exist: active music therapy (participants produce music) and receptive music therapy (participants listen to music), which can be combined.
- Rationale for the Intervention Harp therapy (harpe-thérapie) is a form of receptive music therapy in which a trained therapist plays the harp live during individual or group sessions. Villa Éléonore first introduced harp therapy in late 2023 through a trainee from the first French cohort of harp therapy practitioners. Initial individual sessions with apathetic, bedridden, or palliative residents produced moments of emotional soothing and arousal and were positively received by families. Subsequent group sessions in memory care units in the late afternoon contributed to a general calming effect during and after the session, including a smoother dinner transition and a more serene bedtime routine. Given these positive preliminary observations and the absence of published literature on harp therapy specifically, Villa Éléonore designed the ARPE study to objectively measure the impact of structured harp therapy sessions on behavioral symptoms in memory care residents. The working hypothesis was that harp therapy would reduce disruptive behavioral symptoms (particularly sundowning-related agitation, verbal and non-verbal aggression, and sleep disturbance), reduce psychotropic medication use, and improve staff well-being.
- Study Design ARPE is a prospective, single-center, single-group observational study. No control group or comparator was included. All eligible residents from both memory care units of Villa Éléonore were offered participation. The study followed a longitudinal repeated-measures design over 6 months, including 12 weeks of weekly harp therapy sessions and a 3-month post-intervention follow-up. Regulatory classification: This study is classified as Research Not Involving the Human Person (Recherche N'Impliquant pas la Personne Humaine - RNIPH) under Article L1121-1 of the French Public Health Code, as it does not pursue biological or medical knowledge objectives involving experimental procedures. Data collection is governed by French data protection standards under CNIL Reference Methodology MR-004, which ensures pseudonymization.
- Intervention Description Harp Therapy (Receptive Music Therapy) A certified harp therapist delivers one live group harp therapy session per week for 12 consecutive weeks to all participating residents simultaneously in their memory care unit. Sessions take place in the late afternoon (approximately 5:00-6:30 PM), a period associated with increased behavioral disturbances (sundowning syndrome). Residents are seated comfortably and listen to the harp music live. No active participation (playing, singing, or moving) is required. Session duration is not specified in the protocol but is consistent with standard harp therapy practice (approximately 30-45 minutes). Residents who do not wish to attend on a given week may decline.
- Standard of Care All participants continue to receive their usual nursing home care, including ongoing pharmacological treatments and other NPIs (e.g., physiotherapy, occupational therapy). These are documented at each study visit to assess their potential influence on behavioral outcomes.
- Visit Schedule and Procedures Visit Timing Assessments Pre-inclusion (V-S) Day -10 Study presentation to residents and families; information letter distributed; 10-day non-opposition reflection period Inclusion (V0) Day 0 Non-opposition documented; NPI-ES, CMAI; demographics, clinical data, MMSE, GIR, psychotropic medications (past 6 weeks), other NPIs During 12 sessions Weekly (W1-W12) EVIBE (before and after each session); LIKERT staff well-being (twice/week - once post-session, once on a session-free day) Intermediate visit (V6) Week 6 NPI-ES, CMAI; psychotropic medications and other NPIs (past 6 weeks) End-of-session visit (V12) Week 12 NPI-ES, CMAI; psychotropic medications and other NPIs (past 6 weeks) End-of-study assessment 3 months after last session NPI-ES, CMAI; psychotropic medications and other NPIs (past 3 months)
- Assessment Tools NPI-ES (Neuropsychiatric Inventory - Caregiver Version) The NPI-ES is a validated, structured caregiver-administered interview assessing 12 neuropsychiatric symptom domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders, and appetite/eating abnormalities. Each domain is rated on frequency (1-4) and severity (1-3); domain score = frequency × severity (0-12). Total score ranges from 0 to 144; higher scores indicate greater neuropsychiatric symptom burden. CMAI (Cohen-Mansfield Agitation Inventory) The CMAI is a validated 29-item tool assessing the frequency of agitated behaviors in nursing home residents. Each item is rated on a 7-point scale (1 = never, 7 = several times per hour). Total score ranges from 29 to 203; higher scores indicate greater agitation. EVIBE (Évaluation Immédiate du Bien-Être) The EVIBE is a brief, standardized immediate well-being assessment tool used in French geriatric and psychogeriatric settings. It is administered by a trained clinician (psychologist, occupational therapist, or psychomotor therapist) before and after each harp therapy session to capture immediate changes in residents' perceived well-being. It uses a visual or ordinal scale to quantify well-being. A higher score indicates better well-being. LIKERT Staff Well-Being Scale A Likert-type scale completed by voluntary care staff members to rate their own immediate well-being and their perceived ease of managing residents' behavioral difficulties. Administered twice per week: once after a harp therapy session, and once on a day without a session, to capture potential carry-over effects on staff experience. Score ranges from 1 to 5 (or 1 to 7 depending on the version used); higher scores indicate better well-being / greater ease of managing behavior.
- Statistical Analysis Plan Statistical analyses were conducted by the LNA Santé research support unit using R (version 3.6.1). Given the exploratory nature of the study and the absence of a comparator arm, no formal sample size calculation was performed; enrollment was driven by the estimated inclusion capacity of Villa Éléonore (25-30 residents). No interim analysis was planned. Descriptive statistics: Quantitative variables are described by number of observations, mean, standard deviation, minimum, maximum, 25th/50th/75th percentiles, and 95% bilateral confidence intervals. Qualitative variables are described by frequency counts and relative/absolute percentages. Inferential statistics: Comparisons across the four time points are performed using one-way analysis of variance (ANOVA) for quantitative variables and chi-squared tests for qualitative variables. All tests are bilateral with an overall alpha risk of 5%. A p-value < 0.05 is considered statistically significant. All confidence intervals are 95% bilateral.
- Benefit-Risk Assessment Expected benefits: Reduction in neuropsychiatric symptoms (particularly sundowning-related agitation, verbal/non-verbal aggression, anxiety, sleep disturbances, aberrant motor behavior); reduction in psychotropic medication use; improvement in residents' and care staff's well-being. Identified risks: Paradoxical anxiety reactions; emotional activation (reactivation of distress linked to past trauma or memories); auditory discomfort. All risks are considered minimal. Any adverse reaction may lead to withdrawal from the study at the investigator's discretion.X
- Regulatory and Ethical Framework This study is classified as RNIPH under French law (Article L1121-1 of the Public Health Code) and does not require review by a Committee for the Protection of Persons (CPP). Data collection and processing comply with CNIL Reference Methodology MR-004, pursuant to the French Data Protection Act (Law No. 78-17 of 6 January 1978, as amended). A 10-day non-opposition period was offered to all residents and/or their legal representatives before inclusion. The sponsor (LNA Santé) is the data controller. Data are pseudonymized; the correspondence list is held exclusively by the coordinating investigator. Results will be compiled into an internal report for LNA Santé establishments. No external publication is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harp Therapy Cohort | – | Behavioral: Harp therapy (receptive music therapy)Nursing home residents living in one of the two memory care units (unités protégées) of Villa Éléonore (LNA Santé, France), diagnosed with moderate-to-severe neurodegenerative disease (e.g., Alzheimer's disease or related conditions) and presenting moderate-to-severe disruptive behavioral disorders (agitation, anxiety, sleep disturbances), who received one weekly group live harp therapy session in the late afternoon for 12 consecutive weeks. All eligible residents from both units were offered participation (non-probability, consecutive sampling). Behavioral symptoms, psychotropic medication use, and well-being were assessed at baseline, week 6, week 12, and 3 months after the last session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible residents from the two memory care units of Villa Éléonore, a nursing home operated by LNA Santé in France.
Key inclusion criteria (4 listed)
- Living permanently in a memory care unit (unité protégée) of Villa Éléonore nursing home for at least 2 months
- Diagnosed with a moderate-to-severe neurodegenerative disease (such as Alzheimer's disease or a related condition), AND/OR Mini-Mental State Examination (MMSE) score of 15 or below (or MMSE not evaluable), assessed within the last 12 months
- Presenting moderate-to-severe disruptive behavioral difficulties, such as anxiety, agitation, nighttime wandering, or difficulty falling asleep
- Participant and/or their legal representative has been informed about the study and has not objected to the use of their pseudonymized data
Key exclusion criteria (3 listed)
- Unstabilized psychiatric condition
- Uncorrected hearing impairment causing sensory isolation (i.e., without appropriate hearing aids)
- Documented end-of-life status in the medical record
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 |
|---|---|---|
| Harp therapy (receptive music therapy)arp therapy is a form of receptive music therapy in which a certified harp therapist plays the harp live during group sessions. Participants passively listen to live harp music without any required physical, vocal, or instrumental participation. The acoustic and vibrational properties of the harp are used to promote relaxation, reduce anxiety, and stimulate emotional and memory processes in people with neurodegenerative diseases. In this study, one group session was delivered weekly in the late afternoon (sundowning period) in the memory care unit, for 12 consecutive weeks. Each session lasted approximately 30 to 45 minutes. All eligible residents from both memory care units attended collectively. Harp therapy was provided as part of the facility's non-pharmacological care program and observed prospectively; participants were not assigned to this intervention by the research team. | Behavioural | Harp Therapy Cohort |
Primary outcome
Change from Baseline in Neuropsychiatric Symptoms as Assessed by the Neuropsychiatric Inventory - Caregiver Version (NPI-ES) at Week 6, Week 12, and Month 15
Time frame: Baseline (Day 0), Week 6 (after the 6th session), Week 12 (after the 12th session), and Month 15 (3 months after the last session)
The NPI-ES (Neuropsychiatric Inventory - Échelle pour les Soignants) is a validated, structured caregiver-administered interview assessing 12 neuropsychiatric domains: delusions, hallucinations, agitation/aggression, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, sleep disorders, and appetite changes. Each domain is rated by frequency (1-4) and severity (1-3); domain score = frequency × severity. Total score ranges from 0 to 144; higher score = greater neuropsychiatric symptom burden. Minimum clinically important difference (MCID): not formally established for this population in a single-arm design.
8 secondary outcomes
Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Week 6
Time frame: Baseline (Day 0) and Week 6 (after the 6th harp therapy session)
Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Week 12
Time frame: Baseline (Day 0) and Week 12 (after the 12th harp therapy session)
Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Month 15
Time frame: Baseline (Day 0) and Month 15 (3 months after the last harp therapy session)
Change from Baseline in Psychotropic Medication Use at Week 6
Time frame: Baseline (6 weeks preceding Day 0) and Week 6 (6 weeks preceding the Week 6 visit)
Change from Baseline in Psychotropic Medication Use at Week 12
Time frame: Baseline (6 weeks preceding Day 0) and Week 12 (6 weeks preceding the Week 12 visit)
Change from Baseline in Psychotropic Medication Use at Month 15
Time frame: Baseline (6 weeks preceding Day 0) and Month 15 (3 months preceding the end-of-study visit)
Change in Immediate Resident Well-Being Before and After Each Harp Therapy Session as Assessed by the EVIBE Scale
Time frame: Before and after each weekly harp therapy session, from Week 1 to Week 12 (12 assessments over 12 weeks)
Care Staff Well-Being and Perceived Ease of Managing Behavioral Disorders as Assessed by a Likert Scale
Time frame: Twice weekly throughout the 12-week harp therapy period (Weeks 1-12), approximately 24 assessments per staff member
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 7 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Results of this study will be disseminated through publication in a peer-reviewed scientific journal. Data are governed by the French data protection framework (CNIL Reference Methodology MR-004), which prohibits sharing of pseudonymized individual-level data outside the study framework. The small sample size (25-30 participants) also presents a re-identification risk that precludes IPD sharing.
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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.
Sandrine POINTEREAU principal investigator
Villa Eléonore - LNA SANTE
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 Neurodegenerative Diseases and Behavioral Symptoms, run by LNA SANTE 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 4 inclusion and 3 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 7 Aug 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?
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?
Change from Baseline in Neuropsychiatric Symptoms as Assessed by the Neuropsychiatric Inventory - Caregiver Version (NPI-ES) at Week 6, Week 12, and Month 15 (time frame: Baseline (Day 0), Week 6 (after the 6th session), Week 12 (after the 12th session), and Month 15 (3 months after the last session)). 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 7 Aug 2026.