Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Concordance between the smartwatch application and clinical assessment
研究概览
简要总结
The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality.
The main question it aims to answer is:
- Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep?
详细描述
Participants will answer questionnaires about overall health status, sleep quality and insomnia at the beginning, at 16 days follow-up, and at the end of the study. Participants must use the smartwatch for at least a 12-hour period that includes night time, during a minimum of 30 consecutive days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (30 years old or more);
- •Minimum score of 7 on Pittsburgh Sleep Quality Index;
- •Capable of giving consent.
排除标准
- •Night shift workers;
- •Skin condition that may interfere with optic sensor readings - such as Lupus, Atopic Dermatitis, Vitiligo;
- •Tattoo on the wrist area that may interfere with optic sensor readings;
- •Allergies or sensitivities to the components/materials of the smartwatch;
- •Health condition that may be considered risky/unsafe by the medical team;
- •Pregnant women.
结局指标
主要结局
Concordance between the smartwatch application and clinical assessment
时间窗: 1) at the beginning (start); 2) at the 16-days follow-up (middle); 3) at the 30-days follow-up (end).
Intraclass correlation coefficient calculated between sleep characteristics captured by the smartwatch and scores of all questionnaires
次要结局
未报告次要终点
研究者
Geraldo Lorenzi Filho
Director, Head of the Sleep Laboratory, Principal Investigator, Associate Professor
University of Sao Paulo General Hospital