Recovery and Early Sleep Tracking Using the SuperPatch REM Patch (REST)
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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West Midlands
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Birmingham, West Midlands, 영국, B15 2GW
- Vichag Ltd
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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활성 비교기: 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.
다른 이름들:
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가짜 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of study procedures (recruitment)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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PROMIS Sleep Disturbance score
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
협력자
간행물 및 유용한 링크
일반 간행물
- 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).
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- REST-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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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