An interventional study of SuperPatch REM Patch and Sham REM Patch in Shift Work Sleep Disorder, Shift Work Type Circadian Rhythm Sleep Disorder and Shift Work Sleep Disorders, sponsored by SuperPatch Limited LLC. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by SuperPatch Limited LLC · Not applicable, Interventional, and Treatment
A Phase 1 Feasibility Study of the SuperPatch REM Patch for Post-Night-Shift Sleep Recovery in NHS Doctors
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.
135 studies on the registry are indexed under Sleep Disorders, Circadian Rhythm; 25 are open to participants now.
This study's planned enrollment of 20 is below the median of 59 across 102 interventional studies indexed under Sleep Disorders, Circadian Rhythm.
Browse Sleep Disorders, Circadian Rhythm studies →SuperPatch Limited LLC is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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.
Also known as: REM Patch
A visually identical sham patch without vibrotactile technology, applied using the same timing, wear duration, and procedure as the active patch.
Also known as: Placebo patch
Feasibility of study procedures (recruitment)
Number of participants enrolled per week during the recruitment period. Unit of Measure: Participants/week
Time frame: 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: 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: 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: 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: 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
Time frame: 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: 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: 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: 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: 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: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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 \[confirm min-max for the specific short form used, e.g., 30.7 to 76.5 for the standard 8-item PROMIS Sleep Disturbance short form\]
Time frame: 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)
Time frame: 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: 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: 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: 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: 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: 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: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
Plan to share: No — 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.
Started May 2026 (actual). Primary completion is estimated for Oct 2026, 5 months after the start.
Of 42 interventional studies with no phase under Sleep Disorders, Circadian Rhythm, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
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Sleep Disorders, Circadian Rhythm →