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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06047522
Other study ID # 2021-A02814-37
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date January 3, 2024

Study information

Verified date September 2023
Source RIVAGES
Contact Joël Belmin
Phone 0149594565
Email j.belmin@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 3, 2024
Est. primary completion date January 3, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years to 110 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Intervention

Device:
Casque Lumeen
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.

Locations

Country Name City State
France EHPAD d'Enghien Enghien-les-Bains Val d'Oise
France Hôpital Charles Foix Ivry-sur-Seine Val De Marne
France Maison de retraite la Passerelle Larajasse Rhône
France USLD Arcadie - CHU Rouen Mont-Saint-Aignan Seine Maritime
France EHPAD Louis Grassi Presles Val d'Oise
France Maison de retraite l'arc en ciel Saint-Martin-en-Haut Rhône

Sponsors (1)

Lead Sponsor Collaborator
RIVAGES

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. through study completion, an average of 6 months
Primary 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.
through study completion, an average of 6 months
Primary 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).
through study completion, an average of 6 months
Secondary Security no technical problems endangering the user during sessions, resulting in the session being stopped through study completion, an average of 6 months
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