Resting Metabolic RateOPTIMANCT07781384
Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis
A study testing IGNITE Patch (Active) and Inactive patch in people with Resting Metabolic Rate and Energy Metabolism, run by SuperPatch Limited LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Resting Metabolic Rate, Energy Metabolism, Haptic Technology
- What is being tested?
- IGNITE Patch (Active) and Inactive patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Use of any drugs of abuse
- Implanted pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The OPTIMA Study ("Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis")
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.
Read the 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).
- Being tested
- IGNITE Patch (Active), Inactive patch
- Keywords
- IGNITE patch, SuperPatch, haptic, Vibrotactile Trigger Technology, OPTIMA, RMR, energy metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGNITE Patch (Active)Device
Also called Haptic Vibrotactile Trigger Technology (VTT) 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.
Inactive patchDevice
Also called Sham patch; non-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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Inactive patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Throughout the single or subsequent study visits, from patch application through study completion (approximately 1 hour to 1 hour 45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start5 Jun 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resting Metabolic RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SuperPatch Limited LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clarity Science LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781384
- Sponsor's protocol ID
- OPTIMA-001
- Acronym
- OPTIMA
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 41057672
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OPTIMA Study ("Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis")
- ClinicalTrials.gov ID
- NCT07781384
- Acronym / sponsor ID
- OPTIMA / OPTIMA-001
- Keywords
- IGNITE patch, SuperPatch, haptic, Vibrotactile Trigger Technology, OPTIMA, RMR, energy metabolism
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SuperPatch Limited LLCIndustry (pharma, biotech, devices)
- Collaborators
- Clarity Science LLC
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active IGNITE Patch (Vibrotactile/Haptic) | Active comparator | Device: IGNITE Patch (Active)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. |
| Crossover Sequence (Inactive then Active) | Placebo comparator | Device: Inactive patchParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant
- Use of any drugs of abuse
- Implanted pacemaker or defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGNITE Patch (Active)Also: Haptic Vibrotactile Trigger Technology (VTT) PatchA 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. | Device | Active IGNITE Patch (Vibrotactile/Haptic) |
| Inactive patchAlso: Sham patch; non-VTT patchA 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. | Device | Crossover Sequence (Inactive then Active) |
Primary outcome
Change in Resting Metabolic Rate (RMR) following active patch application
Time frame: 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)
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
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.
1 secondary outcome
Incidence of adverse events associated with patch use
Time frame: Throughout the single or subsequent study visits, from patch application through study completion (approximately 1 hour to 1 hour 45 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 41057672Fason 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGNITE Patch (Active) and Inactive patch in people with Resting Metabolic Rate and Energy Metabolism, run by SuperPatch Limited LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting Metabolic Rate (RMR) following active patch application (time frame: Baseline (pre-patch) and immediately following the 45-minute active patch application, within the single ~1-hour study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.