Actively Recruiting
A Clinical Validation Study on the Assessment of Sleep Apnea by Smart Watch and Smartphone
Led by Peking University First Hospital · Updated on 2024-10-18
295
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
O
OPPO
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how well smartwatches and smartphones can screen for obstructive sleep apnea (OSA) in people suspected of having this condition. OSA is common but often undiagnosed due to challenges in traditional hospital-based testing. With the rise of wearable devices that can monitor multiple physiological signals comfortably and conveniently at home, this study explores their potential as easier screening tools compared to the standard overnight polysomnography (PSG). Participants will wear a smartwatch and use a smartphone to monitor their sleep while undergoing the "gold standard" PSG test supervised overnight in a sleep monitoring room. The study will compare the smartwatch and smartphone data against the PSG results to assess their diagnostic accuracy. This observational study spans from August 2024 to July 2026. During the study, participants will have their sleep monitored by both wearable devices and PSG. Researchers will measure diagnostic sensitivity and specificity as primary outcomes, along with the apnea-hypopnea index (AHI) as a secondary outcome. The study involves signing informed consent and excludes individuals with other severe sleep or medical conditions. Monitoring and assessments occur during the overnight sleep study visit, and participants are observed for the full study duration until July 2026.
CONDITIONS
Brief Title
Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Suspected obstructive sleep apnea
- Scheduled for polysomnography (PSG) test
- Have signed informed consent form
You will not qualify if you...
- Diagnosed other sleep disorders such as central sleep apnea, narcolepsy, sleepwalking, or insomnia with less than 4 hours of sleep nightly
- Severe psychiatric or neurological disorders, or currently taking sedatives or antipsychotic drugs
- Significant somatic diseases affecting sleep like brain injuries, pain, unstable heart conditions, or implanted pacemakers
- Previous CPAP titration or treatment
- Severe respiratory diseases causing low oxygen levels
- Pregnant or lactating women
- Skin diseases or allergies around measurement sites or inability to wear wrist devices due to limb disabilities, skin conditions, vascular disease, edema, tattoos, or hair
- Poor compliance or deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 night
Participants undergo overnight polysomnography (PSG) in a sleep monitoring room while wearing a smartwatch and smartphone to assess sleep apnea.
1 overnight visit (in-person)
Duration - Up to 23 months
Participants' sleep data from smartwatches and smartphones are observed and compared to the PSG results for diagnostic evaluation.
Data collection occurs remotely without additional visits
Trial Site Locations
Total: 1 location
1
Cheng Zhang
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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