DementiaLUMEENCOMPADNCT04769024
Virtual Reality Intervention for the Reduction of Behavioral and Psychological Symptoms of Dementia
A study testing LUMEEN Virtual Reality sessions in people with Dementia and Alzheimer's Disease, run by Hospices Civils de Lyon at 6 sites in France.
Trial summary
Alzheimer's disease and related disorders (AD2) are characterised by cognitive changes and Behavioural and Psychological Symptoms of Dementia (BPSD). According to the French National Authority for Health (2009), Non-Pharmacological Interventions (N PhIs) are to be favo red in the treatment of BPSD. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Dementia, Alzheimer's Disease, Neurocognitive Disorders
- What is being tested?
- LUMEEN Virtual Reality sessions
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 6 sitesFrance
- Study dates
- 2 Dec 2022to 4 Mar 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will have to present a NPI score of 9 or more on at least one of the following items : apathy, agitation, anxiety, depression, aberrant motor behavior.
- The behavioural disorders do not prevent the participation in a session.
- For participants able to give consent:
- Written informed consent to participate in the study
- Informed consent of the participant in the presence of his/her curator for participant under curatorship.
- For participants who are not able to receive information and to give consent:
Show all 9Show fewer
- Written informed consent of the legal representative (tutor) for participants under tutelage.
- Signature of a relative (family member and/or trusted person) of the participant
- The participant has to be affiliated to a social security scheme.
Who cannot join
- Unstable pathology whose nature may interfere with the assessment variables:
- Neurological disorder of infectious origin
- Psychiatric disorder
- Substance abuse
- Severe uncompensated sensory deficit
- History of epilepsy
Show all 10Show fewer
- Pacemaker or severe and/or uncontrolled heart disease (at the discretion of the investigator)
- Visual hallucinations
- Burns and sores on the upper face or scalp
- Unable to express their consent, without a trusted person (family or close friend) and not legally protected
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
EHPAD du Centre Hospitalier du Pays de Craponne Sur Arzon
Craponne-sur-Arzon, 43500
EHPAD du Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
EHPAD Saint-Joseph
Le Puy-en-Velay, 43000
EHPAD Maison Saint-François d'Assise Lyon
Lyon, 69001
EHPAD Korian Saison Dorée
Lyon, 69008
EHPAD Korian Les Aurélias
Pollionnay, 69290
About this study
Official title: Evaluation of the Benefits of an Immersive Virtual Reality Intervention (LUMEEN) for Behavioral and Psychological Symptoms of Dementia in People Living in Residential Aged Care.
Alzheimer's disease and related disorders (AD2) are characterised by cognitive changes and Behavioural and Psychological Symptoms of Dementia (BPSD). According to the French National Authority for Health (2009), Non-Pharmacological Interventions (N PhIs) are to be favo red in the treatment of BPSD. A few NPhIs have already shown their effectiveness in the management of these symptoms, such as music therapy or multi-sensory stimulation, but these techniques require trained staff and/or adapted premises. Over the past decade, innovative techniques have emerged in the field of NPhIs. Virtual Reality (VR) is one of them. Amongst the VR tools, the LUMEEN technology offers a suitable mediation tool for older adults with disabilities which allows to show immersive experiences in calm landscapes known to bring a feeling of well-being (beach, mountain, dolphins, classical music concert, animals in nature, etc.).
The main objective of this study is to evaluate the effect of the LUMEEN Evasion module on the occurrence of BPSD in older adults living in residential aged care.
Read more
Participants will be recruited in nursing homes and randomly assigned to the LUMEEN intervention group or the control group. Participants in the LUMEEN intervention group will attend 12 LUMEEN group session s in which they will be immersed for a few minutes in a selection of landscapes or scenes using virtual reality head-mounted displays and will then have a group discussion about the immersive experience they watched during the session. Participants in the control group will attend 12 non-digital (sensory, social, cognitive, creative) stimulation group sessions in which they will carry out typical pen-and-paper activities for this public which mainly stimulate language, immediate memory, semantic memory, and visual recognition (e.g., definitions, games of 7 differences, reconstruction of proverbs, quizzes…).
The BPSD will be evaluated by the healthcare team before the start of the intervention and after the 12 sessions in both arms of the study (LUMEEN intervention and control) using the Neuropsychiatric Inventory filled out by the nursing staff (NPI). LUMEEN sessions are expected to reduce BPSD (especially apathy) more than control sessions. Thus, participants in the LUMEEN intervention group should have a greater difference between baseline and post-intervention NPI scores than the participants in the control group (in the direction of a reduction of the symptoms in the post-intervention evaluation).
Secondary outcomes will also be measured focusing on apathy, well-being and social interactions. First of all, apathy will be evaluated thanks to the Apathy Inventory - Clinician before and after the interventions in both groups. Then, the state of well-being of the participant will be evaluated thanks to the EVIBE scale completed before and after each session. In addition, social interaction behaviors will be rated using the Social Behaviour Resident Index (SOBRI), collected through a 4-minutes participant observation during each session by an external observer.
LUMEEN sessions are expected to improve these three outcomes more than control sessions. Differences are expected to be observed between the two groups : a) apathy should be lower after the sessions than before and the pre-post-intervention difference should be larger in the LUMEEN intervention group than in the control group; b) well-being should be (in average) higher after the sessions than before and the pre-post-intervention difference should be larger in the LUMEEN intervention group than in the control group ; and c) there should be, on average, more social interactions behaviours during the LUMEEN sessions than during the control sessions.
- Conditions
- Dementia, Alzheimer's Disease, Neurocognitive Disorders
- Being tested
- LUMEEN Virtual Reality sessions, Control/non-digital stimulation sessions
- Keywords
- BPSD, Dementia, Apathy, virtual reality, Alzheimer's disease, Neurocognitive Disorders
- Medical subject headings
- Dementia, Alzheimer Disease, Neurocognitive Disorders, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUMEEN Virtual Reality sessionsDevice
It will consist in carrying out 12 virtual reality sessions in groups of 6 participants, at a rate of 2 per week for approximately 6 weeks, using the LUMEEN "EVASION" module. Each session lasts approximately 45 minutes. This module allows the simultaneous broadcasting in virtual reality headsets of 360° videos accompanied by music about different themes: nature, animals, travel, art and live performance.
The course of an EVASION session is as follows:
- The participants are seated in armchairs in an open environment and sufficiently spaced so that they can move their arms without bumping into each other.
- The facilitator announces the immersion theme of the session
- Participants are equipped with virtual reality head-mounted displays.
- Participants watch the content.
- The head-mounted displays are removed.
- A group discussion encouraging participants to share their feelings and what they have learned from the immersion is conducted by the facilitator.
Control/non-digital stimulation sessionsBehavioural
It will consist in non-digital stimulation (sensory, social, cognitive, creative) group sessions offering various typical pen-and-paper activities for this public which mainly stimulate language, immediate memory, semantic memory, and visual recognition (e.g., definitions, games of 7 differences, reconstruction of proverbs, quizzes…). A set of activities with instructions will be provided to the investigating centres but the choice of activities in each session will be left to the facilitator's decision in order to adapt the sessions to the participants' desires and abilities, as is usually done in such stimulation groups. The sessions will last 45 minutes and will be offered twice a week for 6 weeks by a facilitator or a caregiver with group care training. The sessions will be organized in groups of 6 participants to match the group size of the intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| LUMEEN intervention | Active comparator | Participants in the LUMEEN intervention group will participate in the 12 LUMEEN Virtual Reality sessions of 45 minutes taking place twice a week for 6 weeks, in groups of 6 participants. The content of these sessions is described in the Intervention Description part of this document. Receives: Device: LUMEEN Virtual Reality sessions |
| USUAL activities | Sham comparator | Participants in the control group will participate in the 12 Control/non-digital stimulation sessions of 45 minutes taking place twice a week for 6 weeks, in groups of 6 participants instead of the LUMEEN Virtual Reality sessions. The content of these sessions is described in the Intervention Description part of this document. Receives: Behavioral: Control/non-digital stimulation sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Neuropsychiatric Inventory filled out by the nursing staff (NPI) score between before and after the intervention
The NPI is used to assess the behavioural and psychological symptoms often associated with neurocognitive disorders and dementia. We will compare both groups (LUMEEN intervention and Control) on the differences in NPI scores collected before and after the intervention.
Measured: 12 weeks
Secondary outcomes (3)
Differences between the mean EVIBE scores before the sessions and the mean EVIBE scores after the sessions compared between the two groups (Lumeen intervention and control).
It is a visual analogue scale to report on one's own state of well-being. In response to the question "How do you feel right now?", the participant estimates his/her sense of well-being based on pictograms representing simple facial expressions. The participant's position according to the pictograms correspond to a numerical value from 1 to 5. "1" corresponds to the lowest feeling of well-being and "5" to the highest feeling of well-being. The difference of means between scores observed before and after the intervention will be compared between groups.
Measured: 12 weeks
Differences between scores on the Apathy Inventory - Clinician (AI-Clinician) completed before and after the 12 intervention sessions, compared between the LUMEEN intervention group and the control group.
The Apathy Inventory - Clinician collects information on the presence of apathy according to three dimensions: emotional blunting, loss of initiative, loss of interest. Each dimension is assessed by a clinician according to its frequency (1: sometimes, 2: fairly often, 3: frequently, 4; very frequently) and severity (1: mild, 2: moderate, 3: severe). The score for each dimension is calculated by multiplying the frequency by the severity, resulting in a maximum score of 12. The total score of the AI-Clinician is obtained by adding the scores of the 3 dimensions, obtaining a maximum score of 36.
Measured: 12 weeks
Mean of the Social Behaviour Resident Index (SOBRI) scores completed during each session, compared between LUMEEN intervention and control groups
The SOBRI is used to observe and objectify social interaction behaviours. It consists of two components: social interactions between residents (10 interaction types) and social interactions between residents and staff (6 interaction types). Social interactions are analysed in terms of presence or absence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start2 Dec 2022
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
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
- NCT04769024
- Sponsor's protocol ID
- 69HCL20_1246
- Acronym
- LUMEENCOMPAD
- Status last verified
- Nov 2024
- First submitted
- 8 Feb 2021
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giroux M, Delphin-Combe F, Rion M, Temedda MN, Dauphinot V, Tripoz-Dit-Masson S, Grange C, Garnier-Crussard A, Dautricourt S. Effectiveness of a Virtual Reality Immersion Process as a Nonpharmacological Intervention for Behavioral and Psychological Symptoms of Dementia and Immediate Well-Being in People Living in Nursing Homes: Randomized Controlled Trial. JMIR Form Res. 2026 Oct 6;10:e95542. doi: 10.2196/95542.
PubMed 42837535
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits of an Immersive Virtual Reality Intervention (LUMEEN) for Behavioral and Psychological Symptoms of Dementia in People Living in Residential Aged Care.
- ClinicalTrials.gov ID
- NCT04769024
- Acronym / sponsor ID
- LUMEENCOMPAD / 69HCL20_1246
- Conditions
- Dementia, Alzheimer's Disease, Neurocognitive Disorders
- Keywords
- BPSD, Dementia, Apathy, virtual reality, Alzheimer's disease, Neurocognitive Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 24 Feb 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.
Alzheimer's disease and related disorders (AD2) are characterised by cognitive changes and Behavioural and Psychological Symptoms of Dementia (BPSD). According to the French National Authority for Health (2009), Non-Pharmacological Interventions (N PhIs) are to be favo red in the treatment of BPSD. A few NPhIs have already shown their effectiveness in the management of these symptoms, such as music therapy or multi-sensory stimulation, but these techniques require trained staff and/or adapted premises. Over the past decade, innovative techniques have emerged in the field of NPhIs. Virtual Reality (VR) is one of them. Amongst the VR tools, the LUMEEN technology offers a suitable mediation tool for older adults with disabilities which allows to show immersive experiences in calm landscapes known to bring a feeling of well-being (beach, mountain, dolphins, classical music concert, animals in nature, etc.).
The main objective of this study is to evaluate the effect of the LUMEEN Evasion module on the occurrence of BPSD in older adults living in residential aged care.
Participants will be recruited in nursing homes and randomly assigned to the LUMEEN intervention group or the control group. Participants in the LUMEEN intervention group will attend 12 LUMEEN group session s in which they will be immersed for a few minutes in a selection of landscapes or scenes using virtual reality head-mounted displays and will then have a group discussion about the immersive experience they watched during the session. Participants in the control group will attend 12 non-digital (sensory, social, cognitive, creative) stimulation group sessions in which they will carry out typical pen-and-paper activities for this public which mainly stimulate language, immediate memory, semantic memory, and visual recognition (e.g., definitions, games of 7 differences, reconstruction of proverbs, quizzes…).
The BPSD will be evaluated by the healthcare team before the start of the intervention and after the 12 sessions in both arms of the study (LUMEEN intervention and control) using the Neuropsychiatric Inventory filled out by the nursing staff (NPI). LUMEEN sessions are expected to reduce BPSD (especially apathy) more than control sessions. Thus, participants in the LUMEEN intervention group should have a greater difference between baseline and post-intervention NPI scores than the participants in the control group (in the direction of a reduction of the symptoms in the post-intervention evaluation).
Secondary outcomes will also be measured focusing on apathy, well-being and social interactions. First of all, apathy will be evaluated thanks to the Apathy Inventory - Clinician before and after the interventions in both groups. Then, the state of well-being of the participant will be evaluated thanks to the EVIBE scale completed before and after each session. In addition, social interaction behaviors will be rated using the Social Behaviour Resident Index (SOBRI), collected through a 4-minutes participant observation during each session by an external observer.
LUMEEN sessions are expected to improve these three outcomes more than control sessions. Differences are expected to be observed between the two groups : a) apathy should be lower after the sessions than before and the pre-post-intervention difference should be larger in the LUMEEN intervention group than in the control group; b) well-being should be (in average) higher after the sessions than before and the pre-post-intervention difference should be larger in the LUMEEN intervention group than in the control group ; and c) there should be, on average, more social interactions behaviours during the LUMEEN sessions than during the control sessions.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUMEEN intervention | Active comparator | Device: LUMEEN Virtual Reality sessionsParticipants in the LUMEEN intervention group will participate in the 12 LUMEEN Virtual Reality sessions of 45 minutes taking place twice a week for 6 weeks, in groups of 6 participants. The content of these sessions is described in the Intervention Description part of this document. |
| USUAL activities | Sham comparator | Behavioral: Control/non-digital stimulation sessionsParticipants in the control group will participate in the 12 Control/non-digital stimulation sessions of 45 minutes taking place twice a week for 6 weeks, in groups of 6 participants instead of the LUMEEN Virtual Reality sessions. The content of these sessions is described in the Intervention Description part of this document. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants will have to present a NPI score of 9 or more on at least one of the following items : apathy, agitation, anxiety, depression, aberrant motor behavior.
- The behavioural disorders do not prevent the participation in a session.
- For participants able to give consent:
- For participants who are not able to receive information and to give consent:
- The participant has to be affiliated to a social security scheme.
Key exclusion criteria (10 listed)
- Unstable pathology whose nature may interfere with the assessment variables:
- Severe uncompensated sensory deficit
- History of epilepsy
- Pacemaker or severe and/or uncontrolled heart disease (at the discretion of the investigator)
- Visual hallucinations
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 |
|---|---|---|
| LUMEEN Virtual Reality sessionsIt will consist in carrying out 12 virtual reality sessions in groups of 6 participants, at a rate of 2 per week for approximately 6 weeks, using the LUMEEN "EVASION" module. Each session lasts approximately 45 minutes. This module allows the simultaneous broadcasting in virtual reality headsets of 360° videos accompanied by music about different themes: nature, animals, travel, art and live performance. The course of an EVASION session is as follows: 1. The participants are seated in armchairs in an open environment and sufficiently spaced so that they can move their arms without bumping into each other. 2. The facilitator announces the immersion theme of the session 3. Participants are equipped with virtual reality head-mounted displays. 4. Participants watch the content. 5. The head-mounted displays are removed. 6. A group discussion encouraging participants to share their feelings and what they have learned from the immersion is conducted by the facilitator. | Device | LUMEEN intervention |
| Control/non-digital stimulation sessionsIt will consist in non-digital stimulation (sensory, social, cognitive, creative) group sessions offering various typical pen-and-paper activities for this public which mainly stimulate language, immediate memory, semantic memory, and visual recognition (e.g., definitions, games of 7 differences, reconstruction of proverbs, quizzes…). A set of activities with instructions will be provided to the investigating centres but the choice of activities in each session will be left to the facilitator's decision in order to adapt the sessions to the participants' desires and abilities, as is usually done in such stimulation groups. The sessions will last 45 minutes and will be offered twice a week for 6 weeks by a facilitator or a caregiver with group care training. The sessions will be organized in groups of 6 participants to match the group size of the intervention groups. | Behavioural | USUAL activities |
Primary outcome
Differences in Neuropsychiatric Inventory filled out by the nursing staff (NPI) score between before and after the intervention
Time frame: 12 weeks
The NPI is used to assess the behavioural and psychological symptoms often associated with neurocognitive disorders and dementia. We will compare both groups (LUMEEN intervention and Control) on the differences in NPI scores collected before and after the intervention.
3 secondary outcomes
Differences between the mean EVIBE scores before the sessions and the mean EVIBE scores after the sessions compared between the two groups (Lumeen intervention and control).
Time frame: 12 weeks
Differences between scores on the Apathy Inventory - Clinician (AI-Clinician) completed before and after the 12 intervention sessions, compared between the LUMEEN intervention group and the control group.
Time frame: 12 weeks
Mean of the Social Behaviour Resident Index (SOBRI) scores completed during each session, compared between LUMEEN intervention and control groups
Time frame: 12 weeks
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 3 Dec 2024.
- Derived from this study: PubMed 42837535Giroux M, Delphin-Combe F, Rion M, Temedda MN, Dauphinot V, Tripoz-Dit-Masson S, Grange C, Garnier-Crussard A, Dautricourt S. Effectiveness of a Virtual Reality Immersion Process as a Nonpharmacological Intervention for Behavioral and Psychological Symptoms of Dementia and Immediate Well-Being in People Living in Nursing Homes: Randomized Controlled Trial. JMIR Form Res. 2026 Oct 6;10:e95542. doi: 10.2196/95542.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUMEEN Virtual Reality sessions in people with Dementia and Alzheimer's Disease, run by Hospices Civils de Lyon at 6 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 9 inclusion and 10 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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?
Differences in Neuropsychiatric Inventory filled out by the nursing staff (NPI) score between before and after the intervention (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04769024, which also lists 1 linked publication.
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 3 Dec 2024.