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

NCT06047522 | Unknown

• 1 other identifier: 2021-A02814-37
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Apathy in Dementia; Aged; Virtual Reality; Neurocognitive Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Security

  through study completion, an average of 6 months

Study Arms (1)

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.

Device: Casque Lumeen

Interventions

Casque Lumeen DEVICE

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.

Intervention

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RIVAGES: lead

Study Sites (6)

Maison de retraite la Passerelle

Larajasse, Rhône, 69590, France

RECRUITING

Maison de retraite l'arc en ciel

Saint-Martin-en-Haut, Rhône, 69850, France

RECRUITING

USLD Arcadie - CHU Rouen

Mont-Saint-Aignan, Seine Maritime, 76130, France

RECRUITING

EHPAD d'Enghien

Enghien-les-Bains, Val d'Oise, 95880, France

ACTIVE NOT RECRUITING

EHPAD Louis Grassi

Presles, Val d'Oise, 95590, France

ACTIVE NOT RECRUITING

Hôpital Charles Foix

Ivry-sur-Seine, Val De Marne, 94200, France

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Joël Belmin

CONTACT

0149594565; j.belmin@aphp.fr

Nathavy Um Din

CONTACT

0149594568; livinglab.psga@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: September 21, 2023
• Study Start: January 3, 2023
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)