Status:
RECRUITING
Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
OPPO
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Brief 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 "g...
Detailed 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 b...
Eligibility Criteria
Inclusion
- Age ≥ 18 years; Suspected OSA, scheduled for polysomnography (PSG) Have signed informed consent form.
Exclusion
- 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
Key Trial Info
Start Date :
August 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT06573372
Start Date
August 29 2024
End Date
July 31 2026
Last Update
October 18 2024
Active Locations (1)
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1
Cheng Zhang
Beijing, Beijing Municipality, China, 100034