Evaluating Non-Invasive Haptics During Extreme Exercise | NCT07285252

Studies
Evaluating Non-Invasive Haptics During Extreme Exercise

NCT07285252

Sponsor

SuperPatch Limited LLC

Status

Enrolling by invitation

Last Update Posted

Dec 16, 2025Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

VO2max
Lactate Threshold
Lactate

Interventions

Victory Patch with Haptic Vibrotactile Trigger Technology
Sham patch

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2025Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Dec 3, 2025

First Submission Date that Met QC Criteria

Dec 3, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2025

Last Update Posted Date

Dec 16, 2025Actual

Name	Class
Clarity Science LLC	UNKNOWN
The Altitude Centre	UNKNOWN
Vichag Healthcare Research	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to compare determinants of endurance performance between participants wearing an active patch with haptic vibrotactile trigger technology (VTT) versus a placebo patch without VTT among recreational to competitive runners over a 4-week training period.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TREATMENT	Active Comparator	Victory Patch	Device: Victory Patch with Haptic Vibrotactile Trigger Technology
CONTROL	Placebo Comparator	Sham Comparator	Device: Sham patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Victory Patch with Haptic Vibrotactile Trigger Technology	Device	Active Patch with Haptic Vibrotactile Trigger Technology	TREATMENT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in VO2 Max	Change in VO₂max (mL/kg-¹/min-¹, calculated as a 30-second rolling average)	2-weeks and 4-weeks after baseline assessment

Secondary Outcomes

Measure	Description	Time Frame
Change in Lactate-threshold running speed	Measurement of Lactate-threshold running speed using capillary sampling (LT, km/h-¹), determined using a DmodMax algorithm on lactate-speed curves [15], (2) serum lactate level at threshold (mmol·L-¹).	2-weeks and 4-weeks after baseline assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 18 years and over, that participate in recreational to competitive distance running (>2 structured runs per week), that were able to complete maximal treadmill exercise safely and were able to attend three laboratory visits were invited to participate.

Exclusion Criteria:

Adults with a contraindications to high-intensity treadmill exercise, cardiovascular, metabolic, or musculoskeletal conditions limiting participation, reported use of performance-enhancing drugs, pregnancy, known allergy to adhesives, or current use of neuromodulatory or haptic devices

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Sakr, DO	University of Arizona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Altitude Centre		London	UK	E1 6AH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Upon Initiation of the Study

Access Criteria

Current Study Investigators and associated Research Staff

URL

Not provided

Intervention Model Description

A prospective, non-randomised, double-blinded, parallel-group internal pilot study evaluating the acceptability, safety, recruitment processes, data-collection procedures, and preliminary performance signals of the SuperPatch VICTORY vibrotactile patch in recreational-competitive runners. The Study was designed to inform a future fully-powered interventional study. The study follows the CONSORT Extension for Pilot and Feasibility Trials. The study involves comparison of data from two parallel groups: (1) an active intervention group using SuperPatch VICTORY Patch (intervention) versus (2) a placebo group using a visually identical patch lacking the vibrotactile neurosensory pattern. Participants will be followed for four weeks with lab-based assessments at baseline (Week 0), Week 2, and Week 4.