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临床试验/NCT06573372
NCT06573372已完成不适用

A Clinical Validation Study on the Assessment of Sleep Apnea by Smart Watch and Smartphone

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 377 人开始时间: 2024年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
377
试验地点
1
主要终点
diagnostic specificity, sensitivity

研究概览

简要总结

The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while wearing a smartwatch and smartphone for monitoring. The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA.

详细描述

OSA is common frequently-occurring disease, in the general population prevalence of 9% to 38%[2] (in apnea hypoventilation index (AHI) 5 for the standard or higher). A OSA, according to the global burden of global nearly 1 billion patients with OSA, and our country is, the most populous country[3] in the OSA sick: on the basis of AHI 5 or more, China has 176 million OSA crowd; With AHI ≥15 as the standard, China has 66 million people with OSA. Although the high prevalence of OSA, diagnostic rate was very low, a study shows there are now about 90% of undiagnosed[4] OSA. The serious influence the diagnosis and treatment of OSA and downstream disease prevention and control.

There are many reasons for the low diagnosis rate of OSA. About the danger of OSA patients with insufficient understanding and OSA diagnosis treatment process link is the more important reason. The OSA diagnosis depends on the patient to the hospital, after outpatient service initiated or portable polysomnography evaluation, limited by registered, see a doctor, make an appointment, monitoring, and many other processes, as well as the level of understanding of OSA patients, many patients with OSA don't want to come to the hospital. With the popularity of intelligent wearable devices, intelligent wearable device can effectively monitor the human multiple physiological indicators, and has high comfort, the cost is low, the detection process is not restricted by time and place, etc. Besides smartphones by smart sensors, collect the snoring, heart shock signals (BCG) and respiratory, physiological parameters, such as non-contact multi-parameter sleep monitoring technology, made possible by the. These are the home sleep monitoring way to provide more convenient and easy to use, makes the risk of OSA screening more convenient[5-8].

The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while wearing a smartwatch and smartphone for monitoring. The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years; Suspected OSA, scheduled for polysomnography (PSG) Have signed informed consent form.

排除标准

  • Co-morbid or definitively diagnosed other sleep disorders, such as central sleep apnea syndrome, narcolepsy, sleepwalking, and insomnia patients with less than 4 hours of nightly sleep; Severe psychiatric or neurological disorders (such as bipolar disorder, schizophrenia, epilepsy, etc.), currently taking sedatives or antipsychotic drugs, or patients with neurological, epileptic, or other disorders causing involuntary movements; Significant somatic disease affecting sleep that has been definitively diagnosed, such as craniocerebral diseases or injuries, pain from various causes, unstable angina, uncontrolled heart failure, persistent atrial fibrillation, or atrial flutter; or patients with implanted pacemakers; Patients who have undergone CPAP titration or treatment Patients with other severe respiratory diseases causing hypoxemia, such as Obesity hypoventilation, severe chronic obstructive pulmonary disease, severe interstitial lung disease, or thoracic restrictive disease; or patients with respiratory failure from various causes; Pregnant or lactating women; Subjects with skin diseases or injuries around the measurement site or allergic to the materials of the research equipment and control device Subjects with either of the following conditions, resulting in the inability to use watch/bracelet-type wearable devices to collect information on both sides of the upper limbs: bilateral limb disability; abnormal skin on the wrist; severe occlusive vascular disease of the upper limbs; significant edema of the upper limbs; skin covering the wrist, such as tattoos, severe hair that covers the skin Subjects whose compliance is judged to be poor or for other reasons deemed unsuitable for participation in by the investigator

结局指标

主要结局

diagnostic specificity, sensitivity

时间窗: 29/8/2024-31/7/2026

The diagnostic specificity, sensitivity of OPPO smartphone and smartwatch

次要结局

  • apnea-hypopnea index (AHI)(29/8/2024-31/7/2026)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing MA

Dr.

Peking University First Hospital

研究点 (1)

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