Safety, acceptability, and usability of an immersive gamification technology system for use in patients with behavioral and psychological symptoms of dementia (phase 1 trial)

Abstract

Virtual reality (VR) is increasingly explored as a novel non-pharmacologic approach to manage Alzheimer's disease, particularly the behavioral and psychological symptoms of dementia. This phase 1 study aimed to develop an immersive gamification technology system (ImGTS) for the local context and describe its safety, acceptability, and usability among healthy adults prior to clinical deployment in patients with dementia. The ImGTS was tested on 30 healthy adults using a head-mounted display (HMD; n = 15) or a semi-cave automatic virtual environment (semi-CAVE; n = 15) across four testing sessions. Both qualitative and quantitative questionnaires were administered, with data analyzed through thematic analysis and descriptive statistics. Measures included sense of place, usability, and safety. Participants in both setups reported low VR sickness incidence (four out of 15 participants for both) with decreasing VR sickness questionnaire (VRSQ) scores across sessions (1.50 ± 3.96 to 0 for HMD and 0.78 ± 1.62 to 0 for semi-CAVE). Only mild, mostly oculomotor/disorientation symptoms and slight, transient general discomfort were observed in a minority of participants, using the HMD and semi-CAVE, respectively. Participants also articulated predominantly positive subjective descriptions, with reports of nostalgia and use of strong affective word choices. All participants completed key tasks with little difficulty. The three main activities received “neutral to positive” satisfaction ratings. Overall, our findings indicate that both the HMD and semi-CAVE setups were safe, acceptable, and usable by healthy adult participants. These foundational results support the implementation of phase 2 trials to establish clinical efficacy and tolerability directly within the target population of older individuals living with dementia. NCT05265182