Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis

Overview

This study evaluates whether a drug-free, non-invasive topical patch embedded with Haptic Vibrotactile Trigger Technology (VTT) - the IGNITE Patch (The Super Patch Company) - is associated with changes in resting metabolic rate (RMR) in healthy adults. Approximately 100 healthy men and women, ages 18 to 85, will have their RMR measured at baseline and again after wearing either the active VTT patch or a visually identical inactive patch on the forearm for 45 minutes. Participants in the crossover group wear the inactive patch first, followed by the active patch, with RMR reassessed after each wear period. The entire study visit lasts approximately 1 hour.

The OPTIMA Study ("Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis") is a minimal-risk, single-visit study designed to assess the effect of a commercially available, over-the-counter, drug-free, non-invasive, energy-supporting and metabolic-focused topical patch (IGNITE Patch) embedded with Haptic Vibrotactile Trigger Technology (VTT), compared with a visually identical inactive patch lacking the VTT technology, on resting metabolic rate (RMR) in healthy adult volunteers. After providing informed consent, participants undergo a baseline RMR assessment consisting of 10 minutes of seated rest while breathing and respiration are monitored using a validated RMR testing system. Following a 5-minute waiting period, participants apply a study patch to the forearm and remain seated for 45 minutes, after which RMR is reassessed for a further 10 minutes. Participants assigned to the crossover sequence repeat this process with the alternate patch: those who received the inactive patch first proceed, after another 5-minute wait, to apply the active VTT patch for a third 45-minute wear period, followed by a final RMR assessment. Participants who receive the active patch first are not crossed over and complete the study after a single wear period. Demographic data (age, gender, weight) are collected at enrollment. Approximately 100 healthy men and women, ages 18 to 85, are expected to enroll, and the full study visit lasts approximately 1 hour (longer for participants completing the crossover sequence). The study is sponsored by SRYSTY Holding Co. (The Super Patch Company, Toronto, Canada), conducted by Clarity Science, LLC, and reviewed by Advarra IRB (Protocol OPTIMA-001 / Pro00071426).