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

NCT06505005 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-08

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:

Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT)

DEVICE

Sham Patch without haptic vibrotactile trigger technology (VTT)

Sham Patch without haptic vibrotactile trigger technology (VTT)

Sponsors & Collaborators

  • Clarity Science LLC

    collaborator UNKNOWN

  • SuperPatch Limited LLC

    lead INDUSTRY

Principal Investigators

  • Janet Fason, DO · Stein Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505005 on ClinicalTrials.gov