Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders (APATHIE_RV)

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.

Study Overview

• Status: Recruiting
• Conditions: Neurocognitive Disorders; Virtual Reality; Aged; Apathy in Dementia
• Intervention / Treatment: Device: Casque Lumeen

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joël Belmin; Phone Number: 0149594565; Email: j.belmin@aphp.fr
• Study Contact Backup: Name: Nathavy Um Din; Phone Number: 0149594568; Email: livinglab.psga@gmail.com

Study Locations

• France
  • Rhône
    • Larajasse, Rhône, France, 69590
      • Recruiting
      • Maison de retraite la Passerelle
      • Contact: Lionel Ott
    • Saint-Martin-en-Haut, Rhône, France, 69850
      • Recruiting
      • Maison de retraite l'arc en ciel
      • Contact: Lionel Ott
  • Seine Maritime
    • Mont-Saint-Aignan, Seine Maritime, France, 76130
      • Recruiting
      • USLD Arcadie - CHU Rouen
      • Contact: Laura Capolongo
  • Val De Marne
    • Ivry-sur-Seine, Val De Marne, France, 94200
      • Recruiting
      • Hôpital Charles Foix
      • Contact: Joël Belmin; Phone Number: 0149594565; Email: j.belmin@aphp.fr
      • Sub-Investigator: Nathavy Um Din, MSc
  • Val d'Oise
    • Enghien-les-Bains, Val d'Oise, France, 95880
      • Active, not recruiting
      • EHPAD d'Enghien
    • Presles, Val d'Oise, France, 95590
      • Active, not recruiting
      • EHPAD Louis Grassi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Security	no technical problems endangering the user during sessions, resulting in the session being stopped	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: RIVAGES

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): January 3, 2024
• Study Completion (Estimated): January 3, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: 2021-A02814-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No