Evaluation of a Novel Wearable Device for Circadian Rhythm Monitoring in Healthy, OSA, and Insomnia Participants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Association between circadian phase estimated by the wearable device and circadian phase determined by salivary melatonin sampling.
研究概览
简要总结
This will be a single-center, prospective observational study designed to evaluate the feasibility and accuracy of a new wearable device for non-invasive continuous monitoring of physiological signals to derive circadian rhythm. Melatonin sampling will be included for comparison against wearable-derived measures
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Adults ≥18 years at screening.
- •Able and willing to provide written informed consent.
- •Belonging to one of three strata: (a) healthy controls without diagnosed sleep disorder, (b) patients with physician-diagnosed OSA, or (c) patients with physician-diagnosed insomnia (based on DSM-5/AASM criteria and ISI ≥15)
- •Capable of using a smartphone for app-based data syncing.
- •Willing to comply with study visits, wearable use, and saliva sampling.
排除标准
- •• Dermatologic conditions preventing wearable use.
- •Significant psychiatric or neurologic illness that may impair compliance.
- •Shift work or trans-meridian travel within 2 weeks prior.
- •Currently pregnant
- •Use of medications known to significantly alter circadian rhythm (e.g., exogenous melatonin, beta-blockers).
研究组 & 干预措施
Circadian rhythm monitoring
All participants will be provided a wearable non-invasive device which aims to measure circadian rhythm information
干预措施: Circadian monitoring device (Device)
结局指标
主要结局
Association between circadian phase estimated by the wearable device and circadian phase determined by salivary melatonin sampling.
时间窗: 48 hours
Data taken from melatonin sampling will be compared with data taken from the wearable device to determine the wearables' ability to estimate circadian phase
Feasibility of estimating circadian phase with the myCircadian wearable device. Correlation
时间窗: 48 hours
Circadian phase estimated by the myCircadian wearable device (expressed as clock time of circadian phase in hours) will be compared with circadian phase determined by salivary melatonin sampling, defined as dim-light melatonin onset (DLMO; first salivary melatonin concentration ≥3 pg/mL and ≥2 standard deviations above baseline, expressed in clock time). The strength of agreement between the two measures will be assessed using Pearson correlation coefficient (r).
Association between circadian phase estimated by the wearable device and circadian phase determined by salivary melatonin sampling.
时间窗: 48 hours
Data taken from melatonin sampling will be compared with data taken from the wearable device to determine the wearables' ability to estimate circadian phase
次要结局
未报告次要终点