Clinical trial NCT06708715: Stress Reduction After Use of a Haptic Vibrotactile Trigger Technology Patch: Analysis and Assessment
Official title: Stress Reduction After Use of a Haptic Vibrotactile Trigger Technology Patch: Analysis and Assessment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Keywords: stress
anxiety
SuperPatch
PEACE Patch
Haptic
Vibrotactile Haptic Technology
VTT
Lead sponsor: SuperPatch Limited LLC
Sponsor class: INDUSTRY
Collaborators: name: Clarity Science LLC
First posted: 2024-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 \[for example, The Perceived Stress Scale (PSS) or Medical Outcomes Study Short Form-20 (SF-20)\].

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in patient Perceived Stress Scale (PSS)
timeFrame: From enrollment to end of treatment at 2 weeks
measure: Changes in patient Medical Outcomes Study Short Form-20 (SF-20)
timeFrame: From enrollment to end of treatment at 2 weeks
measure: Changes in the use of prescription and OTC medications
timeFrame: From enrollment to end of treatment at 2 weeks
measure: Demographics and patient satisfaction with the PEACE Patch treatment.
timeFrame: From enrollment to end of treatment at 2 weeks
Secondary outcomes:
Other outcomes:
measure: Any side effects reported by patients will be documented and assessed by clinician and PI
timeFrame: From enrollment to end of treatment at 2 weeks
Locations:
city: Tyrone
country: United States
facility: Stein Medical
state: Georgia
Study officials:
affiliation: University of Miami
name: Jeffrey Gudin, MD
role: PRINCIPAL_INVESTIGATOR
References: