NCT07785960

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2026Oct 2026

Study Start

First participant enrolled

May 15, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 19, 2026

Last Update Submit

August 21, 2026

Conditions

Shift Work Sleep DisorderShift Work Type Circadian Rhythm Sleep DisorderShift Work Sleep Disorders

Keywords

shift work disorderinsomniaSuperPatchREM PatchHaptic Vibrotactile Trigger Technology

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (8)

  • PROMIS Sleep Disturbance score

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

  • Karolinska Sleepiness Scale (KSS) score

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

  • Sleep Onset Latency

    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

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

  • Wake After Sleep Onset (WASO)

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

  • +3 more secondary outcomes

Study Arms (2)

Active REM Patch (Vibrotactile/Haptic)

ACTIVE COMPARATOR

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

Sham REM Patch (Placebo)

SHAM COMPARATOR

Participants apply a visually identical sham patch without vibrotactile technology, following the same timing and duration as the Active arm.

Device: Sham REM Patch

Interventions

SuperPatch REM PatchDEVICE

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
Active REM Patch (Vibrotactile/Haptic)
Sham REM PatchDEVICE

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
Sham REM Patch (Placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vichag Ltd

Birmingham, West Midlands, B15 2GW, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 2265922BACKGROUND

  • 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.

    PMID: 22250775BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    PMID: 41041253BACKGROUND

  • 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).

    BACKGROUND

MeSH Terms

Conditions

Sleep Disorders, Circadian RhythmSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental DisordersSleep Disorders, Intrinsic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-randomized, comparative, parallel-group; double-blind
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 25, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(1)