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Relaxing Virtual Reality Use and Blood Glucose Response to Food (ReViR) Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Aug 30, 2026 → Feb 27, 2027
See other at-risk trials from University of Manitoba

Record History

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  1. Notable Primary completion pushed from Aug 30, 2026 to Feb 27, 2027 Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of May 1, 2026 to Sep 4, 2026
    • Study sites: 0 to 1
    • Study completion date: Feb 1, 2027 to Mar 1, 2027
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 3 of 8 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized cross-over pilot clinical trial aims to evaluate the feasibility and effect of a relaxing virtual reality (VR) experience on glucose response after white bread consumption, compared to a stress-inducing VR, a VR clinical room, and a real clinical room, in healthy adults. Participants will use a head-mounted display to experience either one of the VR environments, or they will simply sit in an actual clinical room for 15 minutes. After this pre-meal condition, participants will consume 66 grams of white bread within 10 minutes, accompanied by 250 mL of water. They will then continue their assigned pre-meal condition for one hour, followed by an additional hour of sitting in the lab for further assessments. The feasibility of the study will be assessed by calculating: 1) Screening to randomization ratio, 2) Recruitment rate of participants per week, 3) Retention rate, 4) Data Completeness of Finger-Prick Glucose Measurements, and 5) VR intervention tolerability measured by Simulator Sickness Questionnaire (SSQ) score. Postprandial glucose response, stress levels, heart rate, and skin conductance will be assessed at baseline (15 minutes before white bread consumption), immediately before consumption (time 0), and at 15, 30, 45, 60, 90, and 120 minutes post-consumption. Palatability will be evaluated immediately after the meal consumption. Motivation to eat will also be assessed at 0, 15, 30, 45, 60, 90, and 120 minutes. Sense of presence will be measured immediately after VR exposure. Additionally, simulator sickness will be assessed at the beginning of the study and after VR exposure. The results will help us better understand the potential feasibility and benefits of using relaxing VR for postprandial glucose management. These findings will also provide evidence to optimize the design of future definitive randomized clinical trials and enhance the development of VR interventions.
Trial Details
NCT Number NCT07541794
Lead Sponsor University of Manitoba
Conditions
(from sponsor)
Post Prandial Blood Glucose, Feasibility Pilot Study
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov