An interventional study of IGNITE Patch (Active) and Inactive patch in Resting Metabolic Rate, Energy Metabolism and Haptic Technology, sponsored by SuperPatch Limited LLC. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by SuperPatch Limited LLC · Not applicable, Interventional, and Basic science
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).
SuperPatch Limited LLC is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo a baseline resting metabolic rate (RMR) assessment, then apply the active IGNITE Patch (embedded with Haptic Vibrotactile Trigger Technology) to the forearm and wear it for 45 minutes, followed by a single post-application RMR assessment.
Device: IGNITE Patch (Active)
Participants undergo a baseline RMR assessment, then apply an inactive (non-VTT) patch to the forearm for 45 minutes, followed by an RMR reassessment. After a 5-minute rest, participants apply the active IGNITE Patch for a further 45 minutes, followed by a final RMR assessment.
Device: Inactive patch
A commercially available, over-the-counter, drug-free, non-invasive topical patch embedded with Haptic Vibrotactile Trigger Technology. Participants apply it to the forearm and wear it for 45 minutes.
Also known as: Haptic Vibrotactile Trigger Technology (VTT) Patch
A drug-free, non-invasive topical patch without embedded VTT technology. Participants apply it to the forearm and wear it for 45 minutes as the first application in the Crossover Sequence.
Also known as: Sham patch; non-VTT patch
Change in Resting Metabolic Rate (RMR) following active patch application
RMR is measured via a validated RMR testing system monitoring breathing and respiration during a 10-minute seated assessment. RMR is compared at baseline and again following a 45-minute application of the active Haptic Vibrotactile Trigger Technology (VTT) IGNITE Patch.
Time frame: Baseline (pre-patch) and immediately following the 45-minute active patch application, within the single ~1-hour study visit
Within-subject difference in RMR change between inactive and active patch exposure (Crossover Sequence)
In participants assigned to the Crossover Sequence, RMR change following the inactive (non-VTT) patch application is compared to RMR change following the subsequent active VTT patch application, providing a within-subject sham-controlled comparison of patch effect on RMR.
Time frame: Baseline, after the 45-minute inactive patch application, and after the subsequent 45-minute active patch application (approximately 1 hour 45 minutes total for Crossover Sequence participants) in one or multiple visits
Incidence of adverse events associated with patch use
Frequency and nature of any adverse events reported by participants during patch application and wear, including skin irritation, discomfort, or other unanticipated effects associated with either the active VTT patch or the inactive patch.
Time frame: Throughout the single or subsequent study visits, from patch application through study completion (approximately 1 hour to 1 hour 45 minutes)
Plan to share: No — Individual participant data will not be shared. This is a minimal-risk study in healthy volunteers (approximately 100 participants) conducted under a HIPAA authorization and Advarra IRB oversight, with participant health data used and disclosed only to the parties specified in the informed consent (the sponsor, Clarity Science, LLC, Advarra IRB, and applicable regulatory authorities) for purposes of conducting this study. Given the modest sample size and the narrow study design, de-identified data sharing beyond these parties was not part of the consented scope, and the data are not intended for broader secondary use. Data are handled in accordance with U.S. HIPAA requirements and the study's HIPAA Authorization.
Started Jun 2023 (actual). Primary completion is estimated for Nov 2026, 41 months after the start.
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