Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea

Last updated: October 16, 2024
Sponsor: Peking University First Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT06573372
2024 Research 347-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Co-morbid or definitively diagnosed other sleep disorders, such as central sleepapnea syndrome, narcolepsy, sleepwalking, and insomnia patients with less than 4hours of nightly sleep; Severe psychiatric or neurological disorders (such asbipolar disorder, schizophrenia, epilepsy, etc.), currently taking sedatives orantipsychotic drugs, or patients with neurological, epileptic, or other disorderscausing involuntary movements; Significant somatic disease affecting sleep that hasbeen definitively diagnosed, such as craniocerebral diseases or injuries, pain fromvarious causes, unstable angina, uncontrolled heart failure, persistent atrialfibrillation, or atrial flutter; or patients with implanted pacemakers; Patients whohave undergone CPAP titration or treatment Patients with other severe respiratorydiseases causing hypoxemia, such as Obesity hypoventilation, severe chronicobstructive pulmonary disease, severe interstitial lung disease, or thoracicrestrictive disease; or patients with respiratory failure from various causes;Pregnant or lactating women; Subjects with skin diseases or injuries around themeasurement site or allergic to the materials of the research equipment and controldevice Subjects with either of the following conditions, resulting in the inabilityto use watch/bracelet-type wearable devices to collect information on both sides ofthe upper limbs: bilateral limb disability; abnormal skin on the wrist; severeocclusive 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 Subjectswhose compliance is judged to be poor or for other reasons deemed unsuitable forparticipation in by the investigator

Study Design

Total Participants: 295
Study Start date:
August 29, 2024
Estimated Completion Date:
July 31, 2026

Study Description

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.

Connect with a study center

  • Cheng Zhang

    Beijing, Beijing 100034
    China

    Active - Recruiting

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