NCT06693193

Personalized Virtual Environments for Managing Responsive Behaviors in Cognitively Impaired Patients: a Feasibility Study

Personalized Virtual Environments for Patients with Cognitive Impairment Exhibiting Responsive Behaviors: Proof-of-Concept and Feasibility Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Fondazione Bruno Kessler · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this feasibility study is to explore the feasibility of using realistic, customizable virtual reality (VR) environments in response to the onset of Responsive Behaviors in elderly residents with cognitive impairment. Specifically, the study will assess; * feasibility through acceptance metrics (including recruitment rate, adherence rate, attrition rate, and tolerance to the intervention); * safety (monitoring for adverse effects related to VR headset use); * user engagement, enjoyment, and overall experience. Participants will be exposed to three VR sessions conducted before, during, or after a situation deemed activating (e.g., personal hygiene activities). Operators will conduct a baseline assessment to identify specific moments when the participant experiences responsive behaviors. Additionally, operators may administer the Oculus VR headset when responsive behaviors occur outside of baseline-identified moments.

Detailed description

Study Site and Environment: Data collection will occur at the Azienda Pubblica di Servizi alla Persona "Margherita Grazioli" in Povo, Trento. The experimental setup will be free from external interference to minimize distractions and ensure a smooth study process. The study will be conducted in familiar, ecologically relevant settings within APSP, selecting environments likely to stimulate activation states in participants. Duration and Procedure: The study is expected to last six months. Each participant will undergo at least three VR sessions about situations that may trigger activation, such as personal hygiene activities. A baseline assessment will pinpoint specific times when participants exhibit responsive behaviors. Additionally, VR sessions may be initiated if responsive behaviors arise outside the predicted times using the Oculus headset. Procedure and Timing for Each VR Session: Preliminary Assessment (Participant Selection) (\~30 minutes): Participants are selected based on inclusion/exclusion criteria and provided with informed consent. Information is collected from clinical records and updated based on the participant's condition. An initial assessment examines responsive behaviors' type, frequency, and timing using demographic information, FAST, NPI, and CMAI. Pre-Session Evaluation (T0) (\~15 minutes): Assessments include pain, responsive behaviors, emotions, anxiety, pleasantness, and discomfort before VR use (using PAINAD and STAI-Y1). Virtual Environment Selection (\~5 minutes): The operator selects the VR environment for the participant through a smartphone linked to the Oculus headset via WiFi. Procedure Explanation and Contextualization (\~5 minutes): A brief overview of the session and VR setup is provided to the participant. Familiarization with Oculus Headset (\~1-2 minutes): A brief period to help the participant acclimate to the VR headset. VR Session and During-Session Evaluation (T1) (\~8 minutes within tolerance): The VR session is audio-visual recorded, with the operator noting participant behaviors and responses (using OERS, Observation Sheet, STAI-Y1, Ad Hoc Questionnaire, PAINAD, and DataSheet2). Post-Session Evaluation (T2) (\~15 minutes): Pain, responsive behaviors, emotions, anxiety, pleasantness, and discomfort are re-evaluated (using PAINAD, DataSheet2, Ad Hoc Questionnaire, STAI-Y1, OERS, NPT-ES, and VRSQ). Final Evaluation (T3) (\~10 minutes): After all sessions, a final assessment using the Cohen-Mansfield Agitation Inventory (CMAI) is conducted.

Conditions

• Cognitive Impairment
• Dementia

Interventions

Type	Name	Description
DEVICE	Immersive Virtual Reality	Individuals will participate in three VR sessions using Oculus headsets, experiencing virtual environments featuring realistic natural stimuli or custom settings tailored to their preferences and valued activities. Each environment allows for the adjustment of auditory elements (such as animal sounds, rustling wind, or specific music), visual elements (such as people, objects, or animals), and the time of day and weather conditions. The operator will use a user-friendly smartphone app to customize the environment, making real-time adjustments to settings and content. Throughout the VR experience, the operator can monitor the participant's visual focus in real-time.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-07-01
• Completion: 2025-09-01
• First posted: 2024-11-18
• Last updated: 2024-11-18

Locations

1 site across 1 country: Italy