Recovery and Early Sleep Tracking Using the SuperPatch REM Patch (REST)

A Phase 1 Feasibility Study of the SuperPatch REM Patch for Post-Night-Shift Sleep Recovery in NHS Doctors

Study Overview

• Status: Enrolling by invitation
• Conditions: Shift Work Sleep Disorder; Shift Work Type Circadian Rhythm Sleep Disorder; Shift Work Sleep Disorders
• Intervention / Treatment: Device: SuperPatch REM Patch; Device: Sham REM Patch

Detailed Description

Night-shift work is associated with disrupted sleep timing, reduced sleep quality, and impaired recovery. The SuperPatch REM Patch is a drug-free, non-invasive vibrotactile technology intended to support recovery signals around sleep, including sleep staging and autonomic metrics. This Phase 1 study is designed to determine feasibility and acceptability in a high-need population (post-night shift NHS doctors), and to estimate preliminary effect sizes on objective wearable sleep metrics and validated subjective recovery outcomes to inform a future double-blind RCT.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2GW
      • Vichag Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult doctors (≥18 years) working regular night shifts
• Able to provide informed consent and comply with remote study procedures
• Willing to wear a sleep-tracking wearable during the study period
• Willing to apply an adhesive study patch during designated post-shift sleep episodes

Exclusion Criteria:

• Known allergy/sensitivity to adhesives or significant dermatologic condition affecting patch placement
• Concurrent use of another device adhered to the body at the same site that could interfere with patch placement
• Any condition judged by investigators to make participation unsafe or data uninterpretable (e.g., acute illness impacting sleep)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active REM Patch (Vibrotactile/Haptic); Participants apply the SuperPatch REM Patch, a drug-free vibrotactile (haptic) device, before post-night-shift sleep for 3-4 sleep episodes.	Device: SuperPatch REM Patch; A drug-free, non-invasive vibrotactile (haptic) patch applied to the skin immediately prior to post-night-shift sleep and removed upon waking, intended to support recovery signals around sleep including sleep staging and autonomic metrics. Applied across 3-4 post-night-shift sleep episodes.; Other Names: REM Patch
Sham Comparator: Sham REM Patch (Placebo); Participants apply a visually identical sham patch without vibrotactile technology, following the same timing and duration as the Active arm.	Device: Sham REM Patch; A visually identical sham patch without vibrotactile technology, applied using the same timing, wear duration, and procedure as the active patch.; Other Names: Placebo patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study procedures (recruitment)	Number of participants enrolled per week during the recruitment period. Unit of Measure: Participants/week	Time Frame: Throughout the recruitment period, up to 8 weeks
Feasibility of Study Procedures (Retention Rate)	Percentage of enrolled participants who complete the study. Unit of Measure: Percentage of participants	Time Frame: Throughout the recruitment period, up to 8 weeks
Feasibility of Study Procedures (Wearable Compliance Rate)	Percentage of expected post-night-shift sleep episodes with a valid wearable sleep record, out of 3-4 expected post-night-shift sleep episodes with a valid wearable sleep record, out of 3-4 expected episodes per participant.	Time Frame: Throughout the recruitment period, up to 8 weeks
Feasibility of Study Procedures (Survey Completion Rate)	Percentage of expected episode surveys (PROMIS Sleep Disturbance and Karolinska Sleepiness Scale) completed, out of 3-4 expected episodes per participant.	Time Frame: Throughout the recruitment period, up to 8 weeks
Feasibility of Study Procedures (Patch Adherence Rate)	Percentage of post-night-shift sleep episodes in which the patch was worn for the full designated wear time. Unit of Measure: Percentage of episodes	Time Frame: Throughout the recruitment period, up to 8 weeks
Total Sleep Time (TST)	Wearable-derived total sleep time per post-night-shift sleep episode, compared between Active and Sham REM Patch groups. Unit of Measure: Minutes	Each post-night-shift sleep episode, up to 4 episodes per participant
Sleep Efficiency	Wearable-derived sleep efficiency (percentage of time in bed spent asleep) per episode, compared between groups. Unit of Measure: Percentage	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
REM Sleep Duration	Wearable-derived REM sleep duration per episode, compared between Active and Sham REM Patch groups. Unit of Measure: Minutes	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
Deep Sleep Duration	Wearable-derived deep (slow-wave) sleep duration per episode, compared between groups. Unit of Measure: Minutes	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
Average Sleeping Heart Rate	Wearable-derived average heart rate during the sleep episode, compared between Active and Sham REM Patch groups. Unit of Measure: Beats per minute	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
Heart Rate Variability (HRV)	Wearable-derived heart rate variability during the sleep episode, compared between groups. Unit of Measure: Milliseconds	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Sleep Disturbance score	Patient-reported sleep quality/disturbance, collected via the PROMIS Sleep Disturbance questionnaire (episode-adapted wording), completed upon waking after each post-night-shift sleep episode. Unit of Measure: T-score on a scale of [confirm min-max for the specific short form used, e.g., 30.7 to 76.5 for the standard 8-item PROMIS Sleep Disturbance short form]	Upon waking, at each of 3-4 post-night-shift sleep episodes per participant
Karolinska Sleepiness Scale (KSS) score	Self-rated state sleepiness at waking, measured using the Karolinska Sleepiness Scale, a brief single-item scale validated in shift-work populations. Unit of Measure: Score on a scale of 1 (extremely alert) to 9 (extremely sleepy, fighting sleep); higher scores indicate greater sleepiness (worse outcome)	Upon waking, at each of 3-4 post-night-shift sleep episodes per participant
Sleep Onset Latency	Wearable-derived time from lights-out to sleep onset, where supported by the participant's device. Unit of Measure: Minutes	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
Incidence of Skin Irritation and Adverse Events Associated with Patch Use	Frequency and severity of skin irritation and other adverse events (e.g., headache, dizziness) associated with wear of either the Active or Sham REM Patch, captured via daily/episode adherence checks and adverse event reporting. Unit of Measure: Number of adverse events	Time Frame: From first patch application through study completion, up to 8 weeks
Wake After Sleep Onset (WASO)	Wearable-derived total wake time after initial sleep onset, where supported by the participant's device. Unit of Measure: Minutes	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
Respiratory Rate During Sleep	Wearable-derived average respiratory rate during the sleep episode, where supported by the participant's device. Unit of Measure: Breaths per minute	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
Peripheral Oxygen Saturation (SpO₂) During Sleep	Wearable-derived average SpO₂ during the sleep episode, where supported by the participant's device. Unit of Measure: Percentage	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
Device-Reported Stress Score	Proprietary wearable-derived stress index, where supported by the participant's device; scoring scale is device-specific. Unit of Measure: Score on device-specific scale	Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

Collaborators and Investigators

• Sponsor: SuperPatch Limited LLC
• Collaborators: Clarity Science LLC; Vichag Healthcare Research

Publications and helpful links

General Publications

• Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
• Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
• Gudin J, Dietze D, Dhaliwal G, Hurwitz P. "Haptic Vibrotactile Trigger Technology: Disrupting the Neuromatrix to Reduce Pain Severity and Interference: Results from the HARMONI Study." Anesth Pain Res. 2022;6(1).
• Fason J, Gudin J, Hurwitz P. Decreased anxiety through haptic technology patch usage: A case-control comparison. J Family Med Prim Care. 2025 Aug;14(8):3529-3537. doi: 10.4103/jfmpc.jfmpc_1981_24. Epub 2025 Sep 24.
• Doghramji P, Dietze A. "Improving Sleep and Quality of Life after Use of a Haptic Vibrotactile Trigger Technology, Drug-Free, Topical Patch: Results from the HARMONI Study." Int J Family Med Healthcare. 2023;2(1).

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 19, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: insomnia; shift work disorder; SuperPatch; REM Patch; Haptic Vibrotactile Trigger Technology
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Chronobiology Disorders; Occupational Diseases; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: REST-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Here's a short, submission-ready description you can paste into the IPD Sharing Statement field:

Individual participant data will not be shared. This is a small Phase 1 feasibility study (N=20) conducted within a narrowly defined population (NHS doctors on night-shift rotations in the UK), where the limited sample size and specificity of the population create a meaningful risk of participant re-identification, even after de-identification. Data collected are intended solely to assess feasibility and generate preliminary effect-size estimates to inform the design of a future randomized controlled trial, consistent with the scope of participant consent obtained for this study. Data will be handled in accordance with UK GDPR, including data minimization and pseudonymization safeguards.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No