Energy Metabolism, Haptic Technology, Resting Metabolic Rate, Vibrotactile Stimulation
Conditions
Keywords
IGNITE patch, SuperPatch, haptic, Vibrotactile Trigger Technology, OPTIMA, RMR, energy metabolism
Brief summary
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.
Detailed description
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).
Interventions
DEVICEIGNITE Patch (Active)
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.
DEVICEInactive 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.
Sponsors
SuperPatch Limited LLC
Clarity Science LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigator/study staff are masked to whether the study patch applied to the participant's forearm contained the active Haptic Vibrotactile Trigger Technology (VTT) or is the visually identical inactive patch. Patch assignment is concealed from both parties throughout the study visit to prevent bias in patch administration and RMR data collection.
Intervention model description
Participants will be assigned to one of two sequences. In the Active-Only sequence, participants will have a baseline resting metabolic rate (RMR) assessment, followed by application of the active Haptic Vibrotactile Trigger Technology (VTT) patch (IGNITE Patch) and a post-application RMR assessment (2 total RMR measurement periods). In the Crossover sequence, participants will have a baseline RMR assessment, followed sequentially by an inactive (non-VTT) patch and then the active VTT patch, with RMR reassessed after each 45-minute patch-wear period (3 total RMR measurement periods). This design enables a within-subject comparison of RMR following inactive versus active patch exposure in the Crossover sequence, in addition to a between-sequence comparison of RMR change associated with the active patch alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 85 years, inclusive * Able to provide written informed consent to participate * Determined to be a healthy volunteer, as assessed by the Investigator
Exclusion criteria
* Pregnant * Use of any drugs of abuse * Implanted pacemaker or defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting Metabolic Rate (RMR) following active patch application | Baseline (pre-patch) and immediately following the 45-minute active patch application, within the single ~1-hour study visit | 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. |
| Within-subject difference in RMR change between inactive and active patch exposure (Crossover Sequence) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events associated with patch use | Throughout the single or subsequent study visits, from patch application through study completion (approximately 1 hour to 1 hour 45 minutes) | 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. |
Countries
United States
Outcome results
None listed