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Completed

NCT Number: NCT06573372

Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jing Ma

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. diagnostic specificity, sensitivity

    Time frame: 29/8/2024-31/7/2026

    The diagnostic specificity, sensitivity of OPPO smartphone and smartwatch

Secondary outcomes

  1. apnea-hypopnea index (AHI)

    Time frame: 29/8/2024-31/7/2026

    The accuracy of apnea-hypopnea index (AHI) determined by smart watch and smartphones were compared with polysomnography (PSG) .

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • OPPO

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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