Topical Patches for Pain and Sleep Disorders

(RESTORE Trial)

Overseen By Peter Hurwitz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SuperPatch Limited LLC

Must not be taking: Drugs of abuse

Disqualifiers: Government healthcare, Implanted device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if drug-free patches can aid in pain relief and improve sleep. Participants will receive either an active patch (FREEDOM or REM Patch) or a placebo (inactive) patch to compare effects. The study will assess how the patches affect pain and sleep over a short period. It suits individuals with acute, moderate pain, such as back or shoulder pain, who are willing to wear a patch during the trial. As an unphased trial, it offers participants the opportunity to explore innovative, medication-free pain relief methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this patch is safe for pain and sleep disorders?

Research has shown that drug-free, non-invasive patches like the FREEDOM or REM Patch are generally safe. One study found that similar patches did not cause any negative effects, suggesting they might be a good option for managing muscle and joint pain. However, a report noted a skin reaction, such as redness and itching, lasting two weeks after using a patch. Those with sensitive skin should consider this. While most people do not experience problems, there is a small chance of skin irritation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because the FREEDOM and REM patches offer a drug-free, non-invasive way to address pain and sleep disorders. Unlike standard treatments that often involve medications like opioids for pain or sedatives for sleep issues, these patches provide a new delivery method that avoids potential side effects and dependency. The patches are applied topically, which is convenient and easy for users. Additionally, with the potential for quicker results — in just a few days — these patches could provide faster relief compared to traditional medications that might take longer to show effects.

What evidence suggests that this patch is effective for pain and sleep disorders?

This trial will evaluate the effectiveness of drug-free, non-invasive patches, specifically the FREEDOM or REM Patch, for pain relief and sleep improvement. Research has shown that similar patches may aid in pain relief and enhance sleep. Studies have found that people using similar patches experience less pain and find daily activities easier. Another study found that these patches can improve sleep quality and duration, leading to a better mood and reduced daytime tiredness. The patches use a special technology that gently stimulates the skin to help the body function better without drugs. This suggests that these patches could effectively manage pain and sleep problems. ^{1 4 6 7 8}

Who Is on the Research Team?

Janet Fason, DO

Principal Investigator

Stein Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 with moderate musculoskeletal pain, such as back or shoulder pain. Participants must be able to consent and agree to wear an adhesive study patch. It's not specified who can't join, but typically those with certain health conditions or sensitivities might be excluded.

Inclusion Criteria

* Ability to provide Informed Consent

* Agrees to wear an adhesive study patch during the study period

I received a study patch for pain from my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Data collected at Baseline prior to first use of active or sham patch

1 day

1 visit (in-person)

Treatment

Participants receive either the active patch (FREEDOM or REM) or sham patch, with data collection at 7 and 14 days

2 weeks

2 visits (in-person)

Crossover

Control group subjects crossover to receive the active patch after completion of the control group study period

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Drug-free, non-invasive patch (FREEDOM or REM Patch)

Trial Overview The study tests a drug-free, non-invasive patch using haptic vibrotactile trigger technology (VTT) against a sham patch without VTT. The goal is to see if the active patch can relieve pain and improve sleep in participants compared to the placebo.

How Is the Trial Designed?

Group I: Active/Treatment Active Control 1 Intervention

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.

Group II: Crossover Active Control 2 Interventions

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.

Group III: Non-Active/Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

SuperPatch Limited LLC

Lead Sponsor

Trials

3

Recruited

400+

Clarity Science LLC

Collaborator

Trials

3

Recruited

400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06505005

Relieving Pain and Improving Sleep: Evaluating Topical ... This IRB-approved, Randomized Controlled Trial (RCT) will measure effectiveness of the pain and sleep patches through assessment of validated scales and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12488145/

Decreased anxiety through haptic technology patch usage [44] This study evaluated an over-the-counter, noninvasive, drug-free patch (PEACE Patch; Super Patch Company, Srysty Holding Co, Toronto, ...

3. link.springer.com link.springer.com/article/10.1007/s40122-025-00780-0

Reducing Pain and Improving Mobility Using Haptic Patch ... The active patch user group had significantly greater improvement in pain severity and reduction in pain interference; in addition, the active ...

4. researchgate.net researchgate.net/publication/376699409_Improving_Sleep_and_Quality_of_Life_after_Use_of_a_Haptic_Vibrotactile_Trigger_Technology_Drug-Free_Topical_Patch_Results_from_the_HARMONI_Study

Improving Sleep and Quality of Life after Use of a Haptic ... This non-pharmacologic, non-invasive, haptic vibrotactile trigger technology (VTT) embedded topical patch improves sleep quality, duration, and quality-of-life ...

5. scivisionpub.com scivisionpub.com/abstract-display.php?id=2711

Improving Sleep and Quality of Life after Use of a ... - Abstract Results also showed positive outcomes in Quality of Life (QoL) components with improvements in daytime fatigue, mood, ability to function at work/daily chores, ...

6. scivisionpub.com scivisionpub.com/pdfs/a-pilot-study-of-the-signal-relieftm-patch-for-the-treatment-of-musculoskeletal-pain-2872.pdf

A Pilot Study of the Signal Relief™ Patch for the Treatment of ... No adverse events were reported. Our findings suggest that the Signal Relief™ may be an effective non-invasive, drug-free option for the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05288114

NCT05288114 | Signal Relief Patch in Musculoskeletal Pain The Signal Relief Patch is an innovative, non-invasive technology that exists as a thin, flexible patch. The patch contains no drugs, wires, or batteries.

8. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20532950&pc=HXT

MAUDE Adverse Event Report: THE SUPER PATCH ... She is not overly sensitive, however after using the patch she experienced a severe skin reaction including redness and itching which persisted over 2 weeks ...