Recovery and Early Sleep Tracking Using the SuperPatch REM Patch
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of study procedures (recruitment)
研究概览
简要总结
A Phase 1 Feasibility Study of the SuperPatch REM Patch for Post-Night-Shift Sleep Recovery in NHS Doctors
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: SuperPatch REM Patch (Device)
Sham REM Patch (Placebo)
Participants apply a visually identical sham patch without vibrotactile technology, following the same timing and duration as the Active arm.
干预措施: Sham REM Patch (Device)
结局指标
主要结局
Feasibility of study procedures (recruitment)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
次要结局
- PROMIS Sleep Disturbance score(Upon waking, at each of 3-4 post-night-shift sleep episodes per participant)
- Karolinska Sleepiness Scale (KSS) score(Upon waking, at each of 3-4 post-night-shift sleep episodes per participant)
- Sleep Onset Latency(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(Time Frame: From first patch application through study completion, up to 8 weeks)
- Wake After Sleep Onset (WASO)(Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant)
- Respiratory Rate During Sleep(Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant)
- Peripheral Oxygen Saturation (SpO₂) During Sleep(Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant)
- Device-Reported Stress Score(Time Frame: Each post-night-shift sleep episode, up to 4 episodes per participant)