An observational study in Neurodegenerative Diseases, Behavioral Symptoms and Dementia, sponsored by LNA SANTE. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by LNA SANTE · Observational
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.
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.
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
436 studies on the registry are indexed under Neurodegenerative Diseases; 143 are open to participants now.
This study's enrollment of 25 is below the median of 186 across 156 observational studies indexed under Neurodegenerative Diseases.
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All eligible residents from the two memory care units of Villa Éléonore, a nursing home operated by LNA Santé in France.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: 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.
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.
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)
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.
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
Same as Outcome 2. Total score ranges from 29 to 203; higher score = greater agitation.
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
Same as Outcome 2. Total score ranges from 29 to 203; higher score = greater agitation.
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
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.
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
Same as Outcome 5. Data extracted from electronic medical record for the 6 weeks preceding the Week 12 assessment.
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
Same as Outcome 5. Data extracted from electronic medical record for the 3 months preceding the end-of-study assessment.
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
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.
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
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.
Time frame: Twice weekly throughout the 12-week harp therapy period (Weeks 1-12), approximately 24 assessments per staff member
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Oct 2025 to primary completion in Mar 2026, 5 months.
Of 82 observational studies under Neurodegenerative Diseases, half reached primary completion within 94 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 216. This study's 5 months is below that.
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