- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468305
SENS'REM - SENSoriality and Multi-Sensory Emotional Reminiscences: a Pilot Study (SENS'REM)
SENS'REM - SENSoriality and Multi-Sensory Emotional Reminiscences: Feasibility of Multi-Sensory Reminiscence in Virtual Reality on Apathy in Elderly People With Cognitive Disorders in Nursing Homes and Long-Term Care Units
SENS'REM is a pilot feasibility study evaluating a new non-drug therapeutic program based on multisensory reminiscence using immersive virtual reality in older adults living in nursing homes or long-term care units who present cognitive impairment and apathy.
Apathy is a frequent symptom in people with neurocognitive disorders. It is characterized by a loss of motivation, reduced interest in activities, and decreased emotional engagement. Apathy strongly affects quality of life, social interactions, and participation in care, and current drug treatments have limited effectiveness. For this reason, non-pharmacological approaches are increasingly recommended.
The SENS'REM program combines virtual reality with personalized multisensory stimulation (visual, auditory, olfactory and gustatory) to help participants relive meaningful autobiographical memories in an immersive and emotionally engaging environment. Each participant receives one session per week for six weeks. The content of the sessions is adapted to the individual life history of each participant.
The primary objective of this study is to evaluate the feasibility of implementing this program in institutional settings, including recruitment, organization, technical aspects, and participant adherence. Secondary objectives include evaluating changes in apathy, quality of life, cognitive functioning, social engagement, participant satisfaction, and the tolerance of the intervention.
The main hypothesis of the study is that a personalized multisensory virtual reality reminiscence program is feasible in nursing home and long-term care settings and may contribute to a reduction in apathy and an improvement in engagement and well-being among older adults with cognitive impairment.
This pilot study will provide essential preliminary data to optimize the intervention and prepare a future larger comparative clinical trial.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne-Julie Vaillant-Ciszewicz, PhD
- Phone Number: +33615938590
- Email: vaillant-ciszewicz.aj@chu-nice.fr
Study Contact Backup
- Name: FRANCESCA FRESCURA
- Phone Number: 06.51.68.18.31
- Email: frescura.f@chu-nice.fr
Study Locations
-
-
-
Nice, France, 06000
- CHU de Nice - Hôpital de Cimiez
-
Contact:
- Anne-Julie Vaillant-ciszewicz
- Phone Number: +33615938590
- Email: vaillant-ciszewicz.aj@chu-nice.fr
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Nice, France
- EPHAD Villa de Rimiez
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Contact:
- Said ATTAILIA, MD
- Phone Number: +33489224200
- Email: SATTAILIA.RIMIEZ@LNA-SaNTE.COM
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men or women aged 70 years or older
- Living in a nursing home (EHPAD) or long-term care unit (USLD) for at least 3 months
- Sufficient French language ability to understand the study procedures
- Presence of apathy confirmed by a positive score on the Apathy Inventory
- Moderate cognitive impairment documented by a Montreal Cognitive Assessment (MoCA) score between 10 and 17
- Affiliated with a social security or health insurance system
- Medical approval for virtual reality exposure (no contraindication)
- Ability to provide informed consent, or consent provided by a legal representative or trusted person when applicable
Exclusion Criteria:
- "Diagnosed psychiatric disorder according to DSM-5 criteria (e.g., schizophrenia, bipolar disorder)
- Severe or acute behavioral disturbances incompatible with study participation
- Neurological comorbidities incompatible with virtual reality use (e.g., Lewy body disease, history of epilepsy)
- Severe sensory impairment (vision, hearing, or olfaction) preventing participation
- Known susceptibility to cybersickness based on the CyberSickness in Virtual Reality Questionnaire (CSQ-VR)
- Presence of a cardiac pacemaker incompatible with virtual reality headset use
- Withdrawal of informed consent at any time during the study"
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multisensory Virtual Reality Reminiscence Intervention
|
Participants receive a personalized multisensory reminiscence therapy program delivered through immersive virtual reality.
Each participant attends one individual session per week for six consecutive weeks.
Sessions last between 30 and 60 minutes and are conducted in a quiet room within the nursing home or long-term care unit.
The virtual environments are selected according to each participant's life history and personal memories, such as familiar places or meaningful contexts.
The intervention combines visual immersion with auditory stimulation, olfactory cues, and, when appropriate, gustatory stimuli.
During each session, participants are encouraged to express memories, emotions, and perceptions associated with the virtual experience.
A trained investigator remains present throughout the session to ensure safety, provide support, and collect observational data.
Sessions are adapted to the participant's tolerance and may be interrupted at any time.
The intervention is designed to stim
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall feasibility of the multisensory virtual reality reminiscence intervention in institutional settings
Time Frame: at 12 months
|
Feasibility is assessed through functional, organizational, technological, and recruitment indicators.
Functional feasibility is defined as the proportion of participants completing at least 50% of planned sessions (minimum 3 of 6 sessions).
Organizational feasibility includes the proportion of sessions conducted as scheduled, and the frequency and reasons for postponed or cancelled sessions.
Technological feasibility evaluates the availability and proper functioning of virtual reality equipment, including hardware or software failures and technical issues.
Recruitment feasibility is assessed by the number of screened participants, the number eligible, and the proportion providing informed consent.
No standardized scale is used; feasibility is described using descriptive quantitative indicators.
|
at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in apathy level measured by the Apathy Inventory
Time Frame: at 12 months
|
The change in apathy is assessed using the Apathy Inventory (AI; Robert et al., 2002), a validated instrument for neurocognitive disorders.
Three complementary versions are used: patient version (8 items, score range 0-32), caregiver version (18 items, score range 0-72), and informant version (18 items, score range 0-72).
Items are rated from 0 (never) to 4 (very often).
Lower scores indicate greater apathy, while higher scores reflect better motivation and engagement.
No formal cut-off score is applied; changes are evaluated by comparing baseline and post-intervention scores across the three sources.
|
at 12 months
|
|
Tolerance of the intervention assessed by cybersickness symptoms
Time Frame: at 12 months
|
Tolerance is assessed using the CyberSickness in Virtual Reality Questionnaire (CSQ-VR; Kourtesis et al., 2023), a validated instrument measuring discomfort related to virtual reality exposure.
The questionnaire includes 20 items assessing symptoms such as nausea, dizziness, visual disturbance, disorientation, and fatigue.
Each item is rated from 0 (none) to 4 (severe), providing a total score reflecting cybersickness severity.
Higher scores indicate greater discomfort.
No validated clinical cut-off is defined; tolerance is evaluated by comparing symptom severity across sessions and at the end of the intervention period.
In addition, all adverse events related to VR use are systematically recorded.
|
at 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anne-Julie Vaillant-Ciszewicz, PhD, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-AOIP-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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