Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches

Part of paid clinical trials in Tyrone, Georgia.

Sponsor
SuperPatch Limited LLC
Study ID
NCT06505005
Status
Enrolling By Invitation

Conditions

  • Insomnia
  • Pain, Acute
  • Pain, Back
  • Sleep
  • Sleep Deprivation
  • Sleep Disorder
  • Sleep Disorders, Circadian Rhythm

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names: — DEVICE
    Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT)
  • Sham Patch without haptic vibrotactile trigger technology (VTT) — DEVICE
    Sham Patch without haptic vibrotactile trigger technology (VTT)

Study Details

This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive patch (FREEDOM or REM Patch; The Super Patch Company Inc.); using validated scales and functional measurement tools along with crossover and control groups within the same subject group not receiving an 'active' patch.

Key Dates

Start date
Sep 20, 2024
Status verified
Nov 2025
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active/Treatment
    Data will be collected at Baseline prior to first use of active patch (FREEDOM or REM) and then 7 days, and then at 14 days after use with the active patch. Baseline and Follow-up functional measurements will also be taken at 7 and 14 days after baseline.
  • Sham Comparator: Non-Active/Control
    Data will be collected at Baseline prior to first use of sham patch and then 7 days, and then at 14 days after use with the sham patch. Baseline and Follow-up functional measurements will also be taken at 7 and 14 days after baseline. Control group subjects will be crossed over to crossover group after completion of control group study period.
  • Active Comparator: Crossover
    Data will be collected at Baseline prior to first use of active patch (FREEDOM or REM) and then 7 days, and then at 14 days after use with the active patch. Baseline and Follow-up functional measurements will also be taken at 7 and 14 days after baseline for all arms.

Primary Outcome Measure

Changes in Pain Severity [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stein MedicalTyroneGeorgia30290-

Find similar trials in Tyrone, GA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Stein Medical· Tyrone, GA

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