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Shift Work Sleep DisorderRESTNCT07785960

Recovery and Early Sleep Tracking Using the SuperPatch REM Patch

A study testing SuperPatch REM Patch in people with Shift Work Sleep Disorder and Shift Work Type Circadian Rhythm Sleep Disorder, run by SuperPatch Limited LLC at 1 site in United Kingdom.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
SuperPatch REM Patch
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
15 May 2026to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site
  • Vichag Ltd

    Birmingham, West Midlands, B15 2GW

Other trials in United Kingdom

About this study

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

Read the 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.

Being tested
SuperPatch REM Patch, Sham REM Patch
Keywords
shift work disorder, insomnia, SuperPatch, REM Patch, Haptic Vibrotactile Trigger Technology
Medical subject headings
Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SuperPatch REM PatchDevice

    Also called 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.

  • Sham REM PatchDevice

    Also called Placebo patch

    A visually identical sham patch without vibrotactile technology, applied using the same timing, wear duration, and procedure as the active patch.

Study groups in NCT07785960
Study groupRoleWhat they receive
Active REM Patch (Vibrotactile/Haptic)Active comparatorParticipants apply the SuperPatch REM Patch, a drug-free vibrotactile (haptic) device, before post-night-shift sleep for 3-4 sleep episodes.
Receives: Device: SuperPatch REM Patch
Sham REM Patch (Placebo)Sham comparatorParticipants apply a visually identical sham patch without vibrotactile technology, following the same timing and duration as the Active arm.
Receives: Device: Sham REM Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of study procedures (recruitment)

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

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

  2. Feasibility of Study Procedures (Retention Rate)

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

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

  3. 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.

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

  4. 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.

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

  5. 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

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

  6. 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

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

  7. Sleep Efficiency

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

    Unit of Measure: Percentage

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

  8. REM Sleep Duration

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

    Unit of Measure: Minutes

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

  9. Deep Sleep Duration

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

    Unit of Measure: Minutes

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

  10. 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

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

  11. Heart Rate Variability (HRV)

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

    Unit of Measure: Milliseconds

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

Secondary outcomes (8)
  1. 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]

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

  2. 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)

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

  3. Sleep Onset Latency

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

    Unit of Measure: Minutes

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

  4. 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

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

  5. 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

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

  6. 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

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

  7. 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

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

  8. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2026
  2. Study start15 May 2026
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-randomized, comparative, parallel-group; double-blind
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07785960
Sponsor's protocol ID
REST-001
Acronym
REST
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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.

    PubMed 2265922
  • 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.

    PubMed 22250775
  • 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.

    PubMed 41041253
  • 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).

Questions about this trial

What is this clinical trial studying?

A study testing SuperPatch REM Patch in people with Shift Work Sleep Disorder and Shift Work Type Circadian Rhythm Sleep Disorder, run by SuperPatch Limited LLC at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of study procedures (recruitment) (time frame: Time Frame: Throughout the recruitment period, up to 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07785960, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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