Recovery and Early Sleep Tracking Using the SuperPatch REM Patch

N/AEnrolling By InvitationNCT07785960

SuperPatch Limited LLC20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

20

Conditions

Shift Work Sleep Disorder Shift Work Type Circadian Rhythm Sleep Disorder Shift Work Sleep Disorders

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.

Sham REM PatchDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Vichag Ltd

Birmingham, West Midlands, United Kingdom

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

NCT07785960 - Recovery and Early Sleep Tracking Using the SuperPatch REM Patch | Crick | Crick