Stress Reduction After Use of a Haptic Vibrotactile Trigger Technology Patch: Analysis and Assessment (STRAVA)

SuperPatch Limited LLC

Status: Active, not recruiting

Conditions: Anxiety; Stress

Treatments: Device: Topical Sham Patch; Device: PEACE Patch

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06708715

STRAVA-001

Details and patient eligibility

About

The purpose of this research study is to collect subject perceptions or feelings about their treatment. Participation includes a survey from individuals who are receiving a stress or anxiety-relieving topical patch [Super Patch PEACE Patch with Haptic Vibrotactile Trigger Technology (VTT)] and assigned to a Treatment Group or given a Sham patch, assigned to the Control Group, to address symptoms or stress and anxiety symptoms using validated scales [for example, The Perceived Stress Scale (PSS) or Medical Outcomes Study Short Form-20 (SF-20)].

Full description

This minimal risk observational study, will evaluate an over the counter (OTC) non-invasive, non- pharmacological patch (Super Patch PEACE Patch; The Super Patch Company Ltd LLC., SRYSTY Holding Co., Toronto, Canada) that is embedded with a proprietary sensory pattern and incorporates haptic vibrotactile trigger technology (VTT) and designed to trigger neural pathways and circuits associated with stress, anxiety, and other cortical networks, with other study participants who receive an 'inactive' (Sham) patch without the embedded VTT technology. The sensory patterns within the active patches are in close symmetry between known EEG patterns and their role in modulating EEG and neuronal circuits within higher brain centers.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages 18 to 85, inclusive
2. Able to provide written informed consent
3. Have received a PEACE Patch from their treating clinician if in treatment group.
4. Is a patient who has been diagnosed with experienced stress or anxiety related issues.
5. Have received a Sham Patch if assigned tot eh Control Group

Exclusion criteria

1. Use of drugs of abuse (illicit or prescription)
2. Pregnancy
3. Existing or planned implantation of Pacemaker or other electrical devices

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

TREATMENT

Active Comparator group

Description:

Subjects will be given a patch that incorporates a vibrotactile haptic technology (VTT) sensory pattern (PEACE Patch)

Treatment:

Device: PEACE Patch

CONTROL

Sham Comparator group

Description:

Subjects will be given a sham patch that does not incorporate vibrotactile haptic technology.

Treatment:

Device: Topical Sham Patch