NCT06573372 Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea
| NCT ID | NCT06573372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Sleep Apnea, Obstructive |
| Study Type | OBSERVATIONAL |
| Enrollment | 295 participants |
| Start Date | 2024-08-29 |
| Primary Completion | 2025-03-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 295 participants in total. It began in 2024-08-29 with a primary completion date of 2025-03-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 "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 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
Frequently Asked Questions
Who can join the NCT06573372 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06573372 currently recruiting?
Yes, NCT06573372 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peking University First Hospital to inquire about joining.
Where is the NCT06573372 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06573372 clinical trial?
NCT06573372 is sponsored by Peking University First Hospital. The trial plans to enroll 295 participants.