Recovery and Early Sleep Tracking Using the SuperPatch REM Patch (REST)
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
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West Midlands
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Birmingham、West Midlands、イギリス、B15 2GW
- Vichag Ltd
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参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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アクティブコンパレータ：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.
他の名前：
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偽コンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Feasibility of study procedures (recruitment)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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PROMIS Sleep Disturbance score
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
協力者
協力者
出版物と役立つリンク
一般刊行物
- 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).
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- REST-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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