CompletedNot Applicable

Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment

Italy23 participantsStarted 2023-01-23

Plain-language summary

The goal of this feasibility study is to investigate the feasibility of a personalized naturalistic Virtual Reality scenario by assessing motion-sickness effects, engagement, pleasantness, and emotions felt considering a sample of individuals with cognitive impairment resident at the Azienda Pubblica di Servizi alla Persona (APSP) "Margherita Grazioli", a long-term care home in Trento (Italy) in collaboration with the Department of General Psychology - University of Padova (Italy) and the Centre for Health and Wellbeing-Fondazione Bruno Kessler (Italy). The current proof-of-concept and feasibility study is a one-session single-centre trial based on a mixed-methods approach inspired by the Obesity-Related Behavioral Intervention Trials (ORBIT) framework for the design (Phase Ib) of digital interventions and their preliminary testing (Phase IIa).

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Italian mother tongue * Clinical diagnosis of Cognitive Impairment (mild, moderate, or severe). Exclusion Criteria: * Palliative care * Clinical diagnosis of psychosis * Severe neurological damage * A clinical diagnosis of epilepsy (or having first-degree relatives diagnosed with epilepsy) - - Cardiac pacemaker or other metal devices * Infectious or gastrointestinal disorders * Open wounds at the level of the face * Motor or visual dysfunctions and neuromuscular pain that prevent the use of Oculus.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessing the general and eye-related physical symptoms of exposure to a virtual reality environment.

Timeframe: Through study completion, an average of 6 months

VR experience tolerability estimated based on the frequency of time spent in the VR context.

Timeframe: Through study completion, an average of 6 months

Usability of the VR apparatus

Timeframe: Through study completion, an average of 6 months

Trial details

NCT IDNCT05863065

SponsorUniversity of Padova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-06

View on ClinicalTrials.gov More Cognitive Impairment trials

Plain-language summary

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Assessing the general and eye-related physical symptoms of exposure to a virtual reality environment.

Timeframe: Through study completion, an average of 6 months

VR experience tolerability estimated based on the frequency of time spent in the VR context.

Timeframe: Through study completion, an average of 6 months

Usability of the VR apparatus

Timeframe: Through study completion, an average of 6 months