Clinical trial NCT06047522: Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders
Official title: Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apathy in Dementia
Aged
Virtual Reality
Neurocognitive Disorders
Lead sponsor: RIVAGES
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tolerance of virtual reality sessions
timeFrame: through study completion, an average of 6 months
measure: Effectiveness of virtual reality sessions on apathy symptoms
timeFrame: through study completion, an average of 6 months
measure: Effectiveness of virtual reality sessions on apathy symptoms
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Security
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Larajasse
country: France
facility: Maison de retraite la Passerelle
state: Rhône
city: Saint-Martin-en-Haut
country: France
facility: Maison de retraite l'arc en ciel
state: Rhône
city: Mont-Saint-Aignan
country: France
facility: USLD Arcadie - CHU Rouen
state: Seine Maritime
city: Enghien-les-Bains
country: France
facility: EHPAD d'Enghien
state: Val d'Oise
city: Presles
country: France
facility: EHPAD Louis Grassi
state: Val d'Oise
city: Ivry-sur-Seine
country: France
facility: Hôpital Charles Foix
state: Val De Marne
Study officials:
References: