ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia
Condition: Dementia Alzheimers
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional

Summary: 
      The proposed research project aims to answer the question "Are immersive technology systems
      effective in the management and treatment of patients with BPSD?". This project is composed
      of three phases and the current study is the first phase. The phase 1 trial aims to create an
      immersive technology system for managing the behavioral and psychological symptoms of
      dementia and determine its acceptability, usability, and safety in the healthy adult
      population.
    

Detailed description: 
      The participants will undergo an intervention using the assigned ImGTS for four sessions
      (twice a week for two weeks), with a maximum of 45 minutes per session. VR trials are in 10-
      to 20-minute periods with introduction, orientation, and provisions for rest periods for
      patient comfort. During the experience, documentation of the patient's reaction and
      interaction with the ImGTS will be recorded by the researchers. The participants will be
      staying at the designated laboratory for not more than one hour.

      Demographic characteristics Demographic characteristics of the participant (age, sex,
      educational attainment, marital status, living conditions, hobbies and interests, previous
      experience with VE applications, existing illnesses, medications) will be collected by the
      researchers through a questionnaire. Personal data, such as name and contact information,
      will only be collected to allow the investigators to contact the participants, as needed.

      Safety Safety will be ensured by assessing a participant's experience of cybersickness. A
      cybersickness questionnaire, the Virtual Reality Sickness Questionnaire will be administered
      after each session. In this self-report questionnaire, nine symptoms will be rated as
      absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue,
      eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when
      the eyes are closed, and vertigo. Answering the questionnaire will take around 10 minutes.

      In the event that a participant will experience severe cybersickness, they may opt to
      discontinue the experience. They will be instructed to remove the HMD or to step out of the
      Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present
      to monitor the participant's symptoms and to attend to them for further management. The
      reason(s) for discontinuing the experience will be documented.

      Acceptability The acceptability of the design will be measured using the Place Probe, a sense
      of place questionnaire. The questionnaire will be administered after each session, and it
      will collect information on a participant's experience in the VE application, particularly on
      (a) their general impression of the environment, (b) the key features of the environment, and
      (c) their feelings of presence. A positive general impression, a memorable environment, and
      high level of presence will indicate that the VE developed is acceptable. This will take
      about 10 minutes to complete.

      Usability Usability testing will be performed according to the PNS ISO/IEC Metrics. The goal
      is to provide continuous improvement in the design and user experience to maximize the three
      components of usability: effectiveness, efficiency, and satisfaction. Additional usability
      metrics will be identified during the first phase of the study. The metrics will be
      specifically adjusted to the target participants as well as the contents to be included in
      the VR system.
    

Intervention name(s): virtual reality
Intervention type(s): Procedure
Intervention description(s): Create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population initially, using semi-Cave or head-mounted display.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: HMD and Semi-Cave
Masking: None (Open Label)
Primary purpose: Other