Shift Work Sleep Disorder, Shift Work Sleep Disorders, Shift Work Type Circadian Rhythm Sleep Disorder
Conditions
Keywords
shift work disorder, insomnia, SuperPatch, REM Patch, Haptic Vibrotactile Trigger Technology
Brief summary
A Phase 1 Feasibility Study of the SuperPatch REM Patch for Post-Night-Shift Sleep Recovery in NHS Doctors
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.
Interventions
DEVICESuperPatch 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.
DEVICESham REM Patch
A visually identical sham patch without vibrotactile technology, applied using the same timing, wear duration, and procedure as the active patch.
Sponsors
SuperPatch Limited LLC
Clarity Science LLC
Vichag Healthcare Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Non-randomized, comparative, parallel-group; double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of study procedures (recruitment) | 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 |
| Feasibility of Study Procedures (Retention Rate) | Time Frame: Throughout the recruitment period, up to 8 weeks | Percentage of enrolled participants who complete the study. Unit of Measure: Percentage of participants |
| Feasibility of Study Procedures (Wearable Compliance Rate) | 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. |
| Feasibility of Study Procedures (Survey Completion Rate) | 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. |
| Feasibility of Study Procedures (Patch Adherence Rate) | 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 |
| Total Sleep Time (TST) | 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 |
| Sleep Efficiency | 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 |
| REM Sleep Duration | 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 |
| Deep Sleep Duration | 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 |
| Average Sleeping Heart Rate | 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 |
| Heart Rate Variability (HRV) | 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
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Sleep Disturbance score | 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 \[confirm min-max for the specific short form used, e.g., 30.7 to 76.5 for the standard 8-item PROMIS Sleep Disturbance short form\] |
| Karolinska Sleepiness Scale (KSS) score | 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) |
| Sleep Onset Latency | 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 |
| Incidence of Skin Irritation and Adverse Events Associated with Patch Use | 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 |
| Wake After Sleep Onset (WASO) | 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 |
| Respiratory Rate During Sleep | 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 |
| Peripheral Oxygen Saturation (SpO₂) During Sleep | 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 |
| Device-Reported Stress Score | 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 |
Countries
United Kingdom
Outcome results
None listed