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Studies

Interventional Recruiting

NCT06579378 on ClinicalTrials.gov

Feasibility Study of Virtual Sail 3D in Cognitive Functions

Official title: Virtual Sail 3D - A Feasibility Study for Enhancing Cognitive Functions in Elderly People

  • Sponsor: University of Cagliari
  • Collaborators: Fondazione di Sardegna
  • Enrollment: 40 (Estimated)
  • Study start: 2024-05-01 (Actual)
  • Primary completion: 2025-11-01 (Estimated)
  • Study completion: 2025-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Randomized Controlled Trial
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief Summary

This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with virtual sailing scenarios among elderly with mild cognitive impairment. CEREBRUM, developed by PRoMIND in association with IDEGO, is the first European tool for enhancing cognitive functions via 3D immersive virtual reality in psychosocial disabilities. Previous studies have shown its effectiveness in improving cognitive functions and well-being in people with bipolar disorders. The software includes modules for memory, learning, cognitive estimations, attention, working memory, and executive functions. For this study, the software was developed with sailing virtual scenarios to make it more enjoyable and engaging, as well as to train other cognitive functions such as motor skills and language abilities among people with disabilities.

Conditions

  • Mild Cognitive Impairment

Intervention / Treatment

  • Device: VSail 3D
  • Other: WEB-Health

Primary Outcome Measures

  • Dropout rates; Proportion of recruited participants among those considered eligible; (T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1))
    Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible.
  • Simulator Sickness Questionnaire (SSQ) (T0 (0 weeks) - T1 (6 weeks))
    Feasibility will be assessed based on side effects through the Simulator Sickness Questionnaire (SSQ), a self-report questionnaire that evaluates the frequency of unwanted effects that may occur due to the use of virtual reality technologies, such as nausea, dizziness, headaches, eye strain, etc. 16 items. The score range is 0-48, with higher scores indicating worse side effects.
  • Self-report satisfaction questionnaire (T1 (6 weeks))
    Feasibility will be assessed based on a Self-report satisfaction questionnaire, constructed ad hoc to evaluate the level of satisfaction with the program as a whole, the effect on psychophysical health, helping and listening abilities demonstrated by the operators, organizational support for activities, satisfaction with initial expectations. The score range is 6-30, with higher scores indicating higher satisfaction.

Countries

Italy

Locations and Investigators

  • University Hospital of Cagliari, Cagliari, Italy (Recruiting)
    • Federica Sancassiani, Prof