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Enrolling by invitation

NCT Number: NCT07785960

Recovery and Early Sleep Tracking Using the SuperPatch REM Patch

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

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Key information

Conditions

Shift Work Sleep Disorder Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Shift Work Sleep Disorders Shift Work Type Circadian Rhythm Sleep Disorder Sleep Disorders, Circadian Rhythm Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vichag Ltd

Birmingham, West Midlands, B15 2GW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SuperPatch REM Patch

Device

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 REM Patch

Device

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

Primary outcomes

  1. Feasibility of study procedures (recruitment)

    Time frame: Time Frame: Throughout the recruitment period, up to 8 weeks

    Number of participants enrolled per week during the recruitment period. Unit of Measure: Participants/week

  2. Feasibility of Study Procedures (Retention Rate)

    Time frame: Time Frame: Throughout the recruitment period, up to 8 weeks

    Percentage of enrolled participants who complete the study. Unit of Measure: Percentage of participants

  3. Feasibility of Study Procedures (Wearable Compliance Rate)

    Time frame: Time Frame: Throughout the recruitment period, up to 8 weeks

    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.

  4. Feasibility of Study Procedures (Survey Completion Rate)

    Time frame: Time Frame: Throughout the recruitment period, up to 8 weeks

    Percentage of expected episode surveys (PROMIS Sleep Disturbance and Karolinska Sleepiness Scale) completed, out of 3-4 expected episodes per participant.

  5. Feasibility of Study Procedures (Patch Adherence Rate)

    Time frame: Time Frame: Throughout the recruitment period, up to 8 weeks

    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

  6. Total Sleep Time (TST)

    Time frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived total sleep time per post-night-shift sleep episode, compared between Active and Sham REM Patch groups.

    Unit of Measure: Minutes

  7. Sleep Efficiency

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived sleep efficiency (percentage of time in bed spent asleep) per episode, compared between groups.

    Unit of Measure: Percentage

  8. REM Sleep Duration

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived REM sleep duration per episode, compared between Active and Sham REM Patch groups.

    Unit of Measure: Minutes

  9. Deep Sleep Duration

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived deep (slow-wave) sleep duration per episode, compared between groups.

    Unit of Measure: Minutes

  10. Average Sleeping Heart Rate

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived average heart rate during the sleep episode, compared between Active and Sham REM Patch groups.

    Unit of Measure: Beats per minute

  11. Heart Rate Variability (HRV)

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived heart rate variability during the sleep episode, compared between groups.

    Unit of Measure: Milliseconds

Secondary outcomes

  1. PROMIS Sleep Disturbance score

    Time frame: Upon waking, at each of 3-4 post-night-shift sleep episodes per participant

    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]

  2. Karolinska Sleepiness Scale (KSS) score

    Time frame: Upon waking, at each of 3-4 post-night-shift sleep episodes per participant

    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)

  3. Sleep Onset Latency

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived time from lights-out to sleep onset, where supported by the participant's device.

    Unit of Measure: Minutes

  4. Incidence of Skin Irritation and Adverse Events Associated with Patch Use

    Time frame: Time Frame: From first patch application through study completion, up to 8 weeks

    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

  5. Wake After Sleep Onset (WASO)

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived total wake time after initial sleep onset, where supported by the participant's device.

    Unit of Measure: Minutes

  6. Respiratory Rate During Sleep

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived average respiratory rate during the sleep episode, where supported by the participant's device.

    Unit of Measure: Breaths per minute

  7. Peripheral Oxygen Saturation (SpO₂) During Sleep

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    Wearable-derived average SpO₂ during the sleep episode, where supported by the participant's device.

    Unit of Measure: Percentage

  8. Device-Reported Stress Score

    Time frame: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant

    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

Sponsors and collaborators

Lead sponsor

SuperPatch Limited LLC

Industry

Collaborators

  • Clarity Science LLC
  • Vichag Healthcare Research

Registry information

Acronym: REST

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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