Evaluating smartwatches and smartphones for diagnosing sleep apnea
A Clinical Validation Study on the Assessment of Sleep Apnea by Smart Watch and Smartphone
Peking University First Hospital · NCT06573372
This study is testing if smartwatches and smartphones can help identify sleep apnea in people who might have it by comparing their readings to a standard sleep test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 295 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06573372 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the diagnostic effectiveness of smartwatches and smartphones in screening for obstructive sleep apnea (OSA) among individuals suspected of having the condition. Participants will undergo a standard overnight polysomnography (PSG) while simultaneously using wearable devices to monitor their physiological indicators. The results from the wearable devices will be compared against the PSG findings to determine their diagnostic value. The study addresses the low diagnosis rate of OSA by leveraging the convenience and accessibility of modern technology.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are suspected of having obstructive sleep apnea and are scheduled for polysomnography.
Not a fit: Patients with other diagnosed sleep disorders, severe psychiatric or neurological conditions, or significant somatic diseases affecting sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the diagnosis rate of obstructive sleep apnea, leading to better patient outcomes.
How similar studies have performed: While the use of wearable technology for health monitoring is gaining traction, this specific approach to diagnosing OSA using smart devices is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Cheng Zhang — Beijing, Beijing Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Obstructive, smart watch, smartphone, Apnea-Hypopnea Index