Recovery and Early Sleep Tracking Using the SuperPatch REM Patch (REST)
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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West Midlands
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Birmingham, West Midlands, Egyesült Királyság, B15 2GW
- Vichag Ltd
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: Active REM Patch (Vibrotactile/Haptic)
Participants apply the SuperPatch REM Patch, a drug-free vibrotactile (haptic) device, before post-night-shift sleep for 3-4 sleep episodes.
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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.
Más nevek:
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Sham Comparator: Sham REM Patch (Placebo)
Participants apply a visually identical sham patch without vibrotactile technology, following the same timing and duration as the Active arm.
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A visually identical sham patch without vibrotactile technology, applied using the same timing, wear duration, and procedure as the active patch.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Feasibility of study procedures (recruitment)
Időkeret: Time Frame: Throughout the recruitment period, up to 8 weeks
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Number of participants enrolled per week during the recruitment period.
Unit of Measure: Participants/week
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Time Frame: Throughout the recruitment period, up to 8 weeks
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Feasibility of Study Procedures (Retention Rate)
Időkeret: Time Frame: Throughout the recruitment period, up to 8 weeks
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Percentage of enrolled participants who complete the study.
Unit of Measure: Percentage of participants
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Time Frame: Throughout the recruitment period, up to 8 weeks
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Feasibility of Study Procedures (Wearable Compliance Rate)
Időkeret: Time Frame: Throughout the recruitment period, up to 8 weeks
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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.
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Time Frame: Throughout the recruitment period, up to 8 weeks
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Feasibility of Study Procedures (Survey Completion Rate)
Időkeret: Time Frame: Throughout the recruitment period, up to 8 weeks
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Percentage of expected episode surveys (PROMIS Sleep Disturbance and Karolinska Sleepiness Scale) completed, out of 3-4 expected episodes per participant.
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Time Frame: Throughout the recruitment period, up to 8 weeks
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Feasibility of Study Procedures (Patch Adherence Rate)
Időkeret: Time Frame: Throughout the recruitment period, up to 8 weeks
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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
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Total Sleep Time (TST)
Időkeret: Each post-night-shift sleep episode, up to 4 episodes per participant
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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
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Sleep Efficiency
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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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
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REM Sleep Duration
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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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
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Deep Sleep Duration
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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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
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Average Sleeping Heart Rate
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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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
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Heart Rate Variability (HRV)
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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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
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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PROMIS Sleep Disturbance score
Időkeret: Upon waking, at each of 3-4 post-night-shift sleep episodes per participant
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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] |
Upon waking, at each of 3-4 post-night-shift sleep episodes per participant
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Karolinska Sleepiness Scale (KSS) score
Időkeret: Upon waking, at each of 3-4 post-night-shift sleep episodes per participant
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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) |
Upon waking, at each of 3-4 post-night-shift sleep episodes per participant
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Sleep Onset Latency
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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Wearable-derived time from lights-out to sleep onset, where supported by the participant's device. Unit of Measure: Minutes |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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Incidence of Skin Irritation and Adverse Events Associated with Patch Use
Időkeret: Time Frame: From first patch application through study completion, up to 8 weeks
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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: From first patch application through study completion, up to 8 weeks
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Wake After Sleep Onset (WASO)
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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Wearable-derived total wake time after initial sleep onset, where supported by the participant's device. Unit of Measure: Minutes |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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Respiratory Rate During Sleep
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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Wearable-derived average respiratory rate during the sleep episode, where supported by the participant's device. Unit of Measure: Breaths per minute |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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Peripheral Oxygen Saturation (SpO₂) During Sleep
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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Wearable-derived average SpO₂ during the sleep episode, where supported by the participant's device. Unit of Measure: Percentage |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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Device-Reported Stress Score
Időkeret: Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
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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: Each post-night-shift sleep episode, up to 4 episodes per participant
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Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Általános kiadványok
- 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.
- 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.
- 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.
- 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).
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- REST-001
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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.
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