Apathy in DementiaAPATHIE_RVNCT06047522
Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders
A study testing Casque Lumeen in people with Apathy in Dementia and Aged, run by RIVAGES at 6 sites in France.
Trial summary
The goal of this clinical trial is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Apathy in Dementia, Aged, Virtual Reality
- What is being tested?
- Casque Lumeen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesFrance
- Study dates
- 3 Jan 2023to 3 Jan 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 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Persons over 65 years of age
- Persons living in nursing homes or hospitalized in long-term care
- Persons with correct vision or vision corrected by glasses
- People with no hearing problems, or with hearing loss corrected by a hearing aid
- Person with a major neurocognitive disorder
- Person with a Mini Mental State Examination (MMSE) cognitive score <26
- Individuals with documented apathy
Who cannot join
- Person with a history of epilepsy
- Persons wearing a pacemaker
- Person with open wounds of the face or skull
- Disabling headache or neck pain
- Person at the immediate end of life or in active palliative care
- Person with a contagious disease
Show all 10Show fewer
- People who are bedridden or unable to get into a wheelchair
- Persons with severe neurological impairment
- Person with severe behavioral disorders endangering self or staff
- Persons unable to give oral consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 4 recruiting
- Active, not recruiting
EHPAD d'Enghien
Enghien-les-Bains, Val d'Oise, 95880
- Recruiting
Hôpital Charles Foix
Ivry-sur-Seine, Val De Marne, 94200
Joël Belmin, 0149594565, j.belmin@aphp.fr
Nathavy Um Din, MSc
- Recruiting
Maison de retraite la Passerelle
Larajasse, Rhône, 69590
Lionel Ott
- Recruiting
USLD Arcadie - CHU Rouen
Mont-Saint-Aignan, Seine Maritime, 76130
Laura Capolongo
- Active, not recruiting
EHPAD Louis Grassi
Presles, Val d'Oise, 95590
- Recruiting
Maison de retraite l'arc en ciel
Saint-Martin-en-Haut, Rhône, 69850
Lionel Ott
About this study
The goal of this clinical trial is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders. The main questions it aims to answer are:
- Does virtual reality have an impact on symptoms of apathy in the elderly?
- Is virtual reality well tolerated by the elderly? Participants will benefit from a 3-session virtual reality headset program with a healthcare professional. They will have one session per week for 3 weeks. They will be observed by another professional, who will complete observation grids on apathy, engagement in activity and tolerance of the virtual reality headset.
There is not a comparison group: Researchers will compare the scores before and after the intervention: the participant will be his own control.
Read the detailed description
This study is a multicenter interventional exploratory study in two nursing homes and a geriatric long-term care service. Thirty patients will be included. They will be recruited from residents of the long-term care departments of two hospitals, and 4 nursing homes.
A pre- and post-intervention comparison will be made by assessing apathy using the apathy inventory and the neuropsychiatric inventory in the care team version. A comparison of participants' engagement will be carried out through ecological observation of the interventions. This will be objectivized by the Caregiver Interaction Behavior Scale (ECPAI) before the immersion program, and during the first and third virtual reality sessions. An ECPAI scale taken during a conventional animation prior to the program will establish a baseline state for the participant.
The main goal is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders.
- Conditions
- Apathy in Dementia, Aged, Virtual Reality, Neurocognitive Disorders
- Being tested
- Casque Lumeen
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casque LumeenDevice
Participants will take part in virtual reality sessions via headset. They will benefit from a before/after evaluation, and a 3-week intervention where they will have 1 virtual reality session per week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participant will benefit from three immersion sessions with the virtual reality headset, either individually or in a group session, accompanied by a team member trained in the use of the headset (psychomotrician, occupational therapist, doctor, psychologist, facilitator). At each session, the scale of observed emotions and the cybermalaise questionnaire will be completed (T1, T2, T3). At sessions 1 (T1) and 3 (T3), the investigator will administer the ECPAI behavior scale. Receives: Device: Casque Lumeen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of virtual reality sessions
No change in Simulator Sickness Questionnaire (SSQ), or maintenance of "none" and "slight" scores. There are 16 items, each item is rated with the scale from none, slight, moderate to severe. After some calculations you have 3 subscores : Computation of nausea (N), oculomotor r disturbance (O), disorientation (D), and total simulator sickness (TS) scores.
Measured: through study completion, an average of 6 months
Effectiveness of virtual reality sessions on apathy symptoms
Decrease in apathy scores on the Apathy Inventory (IA) (NPI). IA clinician assessment (0 to 4 score) has to take into account several factors: useful observation points, Patient history and social environment, personality, Information coming from the caregiver, Patient's responses to the clinical domains, autonomy.
A score equal or upper to 4 is pathological.
Measured: through study completion, an average of 6 months
Effectiveness of virtual reality sessions on apathy symptoms
Decrease in apathy scores on the Neuropsychiatric Inventory (NPI), caregiver version.
The NPI-ES is based on responses from a member of the healthcare team involved in the patient's care. Responses refer to behaviours that have been present over the past week or other well-defined during other well-defined periods (e.g. 1 month ago, or since the last assessment). Answers should be brief, and can be formulated as "yes" or "no". In clinical practice, the most relevant factor to consider is the frequency x severity score for each area (a score greater than 2 is pathological).
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Security
no technical problems endangering the user during sessions, resulting in the session being stopped
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start3 Jan 2023
- Primary completion3 Jan 2024 (estimated)
- Study completion3 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apathy in DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RIVAGES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047522
- Sponsor's protocol ID
- 2021-A02814-37
- Acronym
- APATHIE_RV
- Status last verified
- Sep 2023
- First submitted
- 20 Jul 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Each co-investigator coordinates his or her inclusions with the principal investigator, and sends him or her the data collected via secure messaging. The co-investigator is responsible for collating all the data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT06047522
- Acronym / sponsor ID
- APATHIE_RV / 2021-A02814-37
- Conditions
- Apathy in Dementia, Aged, Virtual Reality, Neurocognitive Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RIVAGESUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 3 Jan 2024 (estimated)
- Study completion
- 3 Jan 2024 (estimated)
- First posted
- 21 Sep 2023 (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 goal of this clinical trial is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders. The main questions it aims to answer are:
- Does virtual reality have an impact on symptoms of apathy in the elderly?
- Is virtual reality well tolerated by the elderly? Participants will benefit from a 3-session virtual reality headset program with a healthcare professional. They will have one session per week for 3 weeks. They will be observed by another professional, who will complete observation grids on apathy, engagement in activity and tolerance of the virtual reality headset.
There is not a comparison group: Researchers will compare the scores before and after the intervention: the participant will be his own control.
Detailed description
This study is a multicenter interventional exploratory study in two nursing homes and a geriatric long-term care service. Thirty patients will be included. They will be recruited from residents of the long-term care departments of two hospitals, and 4 nursing homes.
A pre- and post-intervention comparison will be made by assessing apathy using the apathy inventory and the neuropsychiatric inventory in the care team version. A comparison of participants' engagement will be carried out through ecological observation of the interventions. This will be objectivized by the Caregiver Interaction Behavior Scale (ECPAI) before the immersion program, and during the first and third virtual reality sessions. An ECPAI scale taken during a conventional animation prior to the program will establish a baseline state for the participant.
The main goal is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Casque LumeenThe participant will benefit from three immersion sessions with the virtual reality headset, either individually or in a group session, accompanied by a team member trained in the use of the headset (psychomotrician, occupational therapist, doctor, psychologist, facilitator). At each session, the scale of observed emotions and the cybermalaise questionnaire will be completed (T1, T2, T3). At sessions 1 (T1) and 3 (T3), the investigator will administer the ECPAI behavior scale. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Persons over 65 years of age
- Persons living in nursing homes or hospitalized in long-term care
- Persons with correct vision or vision corrected by glasses
- People with no hearing problems, or with hearing loss corrected by a hearing aid
- Person with a major neurocognitive disorder
Key exclusion criteria (10 listed)
- Person with a history of epilepsy
- Persons wearing a pacemaker
- Person with open wounds of the face or skull
- Disabling headache or neck pain
- Person at the immediate end of life or in active palliative care
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 |
|---|---|---|
| Casque LumeenParticipants will take part in virtual reality sessions via headset. They will benefit from a before/after evaluation, and a 3-week intervention where they will have 1 virtual reality session per week. | Device | Intervention |
Primary outcome
Tolerance of virtual reality sessions
Time frame: through study completion, an average of 6 months
No change in Simulator Sickness Questionnaire (SSQ), or maintenance of "none" and "slight" scores. There are 16 items, each item is rated with the scale from none, slight, moderate to severe. After some calculations you have 3 subscores : Computation of nausea (N), oculomotor r disturbance (O), disorientation (D), and total simulator sickness (TS) scores.
Effectiveness of virtual reality sessions on apathy symptoms
Time frame: through study completion, an average of 6 months
Decrease in apathy scores on the Apathy Inventory (IA) (NPI). IA clinician assessment (0 to 4 score) has to take into account several factors: useful observation points, Patient history and social environment, personality, Information coming from the caregiver, Patient's responses to the clinical domains, autonomy. A score equal or upper to 4 is pathological.
Effectiveness of virtual reality sessions on apathy symptoms
Time frame: through study completion, an average of 6 months
Decrease in apathy scores on the Neuropsychiatric Inventory (NPI), caregiver version. The NPI-ES is based on responses from a member of the healthcare team involved in the patient's care. Responses refer to behaviours that have been present over the past week or other well-defined during other well-defined periods (e.g. 1 month ago, or since the last assessment). Answers should be brief, and can be formulated as "yes" or "no". In clinical practice, the most relevant factor to consider is the frequency x severity score for each area (a score greater than 2 is pathological).
1 secondary outcome
Security
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No. Each co-investigator coordinates his or her inclusions with the principal investigator, and sends him or her the data collected via secure messaging. The co-investigator is responsible for collating all the data.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casque Lumeen in people with Apathy in Dementia and Aged, run by RIVAGES 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 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joël Belmin (0149594565, j.belmin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of virtual reality sessions (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. 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 21 Sep 2023.