← Back to Search

Active/Treatment for Sleep Wake Disorder (RESTORE Trial)

N/A

Waitlist Available

Led By Janet Fason, DO

Research Sponsored by SuperPatch Limited LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

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.

Eligible Conditions

Sleep Wake Disorder
Sleep Deprivation
Sleep
Circadian Rhythm Disorder
Back Pain
Acute Pain
Insomnia
Sleep Disorders

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Pain Interference

Changes in Pain Severity

Changes in Range of Motion and Flexibility

+3 more

Secondary study objectives

Changes in Awakenings during sleep

Changes in Pain Medication Use

Changes in Sleep Medication Use

Other study objectives

Any side effects reported by patients will be documented and assessed by clinician and PI

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Active/TreatmentActive Control1 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: CrossoverActive Control2 Interventions

Group III: Non-Active/ControlPlacebo Group1 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.

Do I qualify?Apply below to find out