Recovery and Early Sleep Tracking Using the SuperPatch REM Patch (REST)
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
West Midlands
-
Birmingham、West Midlands、英国、B15 2GW
- Vichag Ltd
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
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.
其他名称：
|
|
假比较器：Sham REM Patch (Placebo)
Participants apply a visually identical sham patch without vibrotactile technology, following the same timing and duration as the Active arm.
|
A visually identical sham patch without vibrotactile technology, applied using the same timing, wear duration, and procedure as the active patch.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of study procedures (recruitment)
大体时间：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
|
Time Frame: Throughout the recruitment period, up to 8 weeks
|
|
Feasibility of Study Procedures (Retention Rate)
大体时间：Time Frame: Throughout the recruitment period, up to 8 weeks
|
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)
大体时间：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.
|
Time Frame: Throughout the recruitment period, up to 8 weeks
|
|
Feasibility of Study Procedures (Survey Completion Rate)
大体时间：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.
|
Time Frame: Throughout the recruitment period, up to 8 weeks
|
|
Feasibility of Study Procedures (Patch Adherence Rate)
大体时间：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 |
Time Frame: Throughout the recruitment period, up to 8 weeks
|
|
Total Sleep Time (TST)
大体时间：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 |
Each post-night-shift sleep episode, up to 4 episodes per participant
|
|
Sleep Efficiency
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
|
REM Sleep Duration
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
|
Deep Sleep Duration
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
|
Average Sleeping Heart Rate
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
|
Heart Rate Variability (HRV)
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PROMIS Sleep Disturbance score
大体时间：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] |
Upon waking, at each of 3-4 post-night-shift sleep episodes per participant
|
|
Karolinska Sleepiness Scale (KSS) score
大体时间：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) |
Upon waking, at each of 3-4 post-night-shift sleep episodes per participant
|
|
Sleep Onset Latency
大体时间：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 |
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
大体时间：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 |
Time Frame: From first patch application through study completion, up to 8 weeks
|
|
Wake After Sleep Onset (WASO)
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
|
Respiratory Rate During Sleep
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
|
Peripheral Oxygen Saturation (SpO₂) During Sleep
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
|
Device-Reported Stress Score
大体时间：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 |
Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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).
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- REST-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.