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

NCT07781384 | Enrolling By Invitation

• 1 other identifier: OPTIMA-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Resting Metabolic Rate; Energy Metabolism; Haptic Technology; Vibrotactile Stimulation

Keywords

IGNITE patch; SuperPatch; haptic; Vibrotactile Trigger Technology; OPTIMA; RMR; energy metabolism

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

Secondary Outcomes (1)

• 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)

Study Arms (2)

Active IGNITE Patch (Vibrotactile/Haptic)

ACTIVE COMPARATOR

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)

Crossover Sequence (Inactive then Active)

PLACEBO COMPARATOR

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

Interventions

IGNITE Patch (Active) DEVICE

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

Active IGNITE Patch (Vibrotactile/Haptic)

Inactive patch DEVICE

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

Crossover Sequence (Inactive then Active)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Use of any drugs of abuse
• Implanted pacemaker or defibrillator

Sponsors & Collaborators

• SuperPatch Limited LLC: lead
• Clarity Science LLC: collaborator

Study Sites (1)

Stein Medical

Tyrone, Georgia, 30290, United States

Location

Related Publications (1)

• Fason J, Hurwitz P, Gudin J. Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study. Pain Ther. 2025 Dec;14(6):1797-1807. doi: 10.1007/s40122-025-00780-0. Epub 2025 Oct 8.

  PMID: 41057672 BACKGROUND

MeSH Terms

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: June 5, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)