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

Virtual Reality Clinical Trial

— APATHIE_RV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047522
• Other study ID #: 2021-A02814-37
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aged
• Apathy in Dementia
• Neurocognitive Disorders
• Virtual Reality

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