MedPath

Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea

Not yet recruiting
Conditions
Sleep Apnea, Obstructive
Registration Number
NCT06573372
Lead Sponsor
Peking University First Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not yet recruiting
Sex
All
Target Recruitment
295
Inclusion Criteria

Inclusion Criteria:<br><br> - Age = 18 years; Suspected OSA, scheduled for polysomnography (PSG) Have signed<br> informed consent form.<br><br>Exclusion Criteria:<br><br> - Co-morbid or definitively diagnosed other sleep disorders, such as central sleep<br> apnea syndrome, narcolepsy, sleepwalking, and insomnia patients with less than 4<br> hours of nightly sleep; Severe psychiatric or neurological disorders (such as<br> bipolar disorder, schizophrenia, epilepsy, etc.), currently taking sedatives or<br> antipsychotic drugs, or patients with neurological, epileptic, or other disorders<br> causing involuntary movements; Significant somatic disease affecting sleep that has<br> been definitively diagnosed, such as craniocerebral diseases or injuries, pain from<br> various causes, unstable angina, uncontrolled heart failure, persistent atrial<br> fibrillation, or atrial flutter; or patients with implanted pacemakers; Patients who<br> have undergone CPAP titration or treatment Patients with other severe respiratory<br> diseases causing hypoxemia, such as Obesity hypoventilation, severe chronic<br> obstructive pulmonary disease, severe interstitial lung disease, or thoracic<br> restrictive disease; or patients with respiratory failure from various causes;<br> Pregnant or lactating women; Subjects with skin diseases or injuries around the<br> measurement site or allergic to the materials of the research equipment and control<br> device Subjects with either of the following conditions, resulting in the inability<br> to use watch/bracelet-type wearable devices to collect information on both sides of<br> the upper limbs: bilateral limb disability; abnormal skin on the wrist; severe<br> occlusive vascular disease of the upper limbs; significant edema of the upper limbs;<br> skin covering the wrist, such as tattoos, severe hair that covers the skin Subjects<br> whose compliance is judged to be poor or for other reasons deemed unsuitable for<br> participation in by the investigator

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
diagnostic specificity, sensitivity
Secondary Outcome Measures
NameTimeMethod
apnea-hypopnea index (AHI)
© Copyright 2025. All Rights Reserved by MedPath