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RECRUITING

NCT07908160

Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

In recent years, wearable and contactless devices, including smart rings, smart bands/watches, and smart mattresses, have developed rapidly and can continuously collect multidimensional data such as heart rate, oxygen saturation, respiration, body movement, snoring, body temperature, and environmental parameters. Nevertheless, most current consumer-grade or wellness-oriented devices have not been trained and validated using large polysomnography (PSG)-synchronized reference datasets. Their accuracy, robustness, and interpretability in people with insomnia, obstructive sleep apnea (OSA), and other sleep disorders therefore require systematic evaluation. Leveraging a multicenter clinical sleep-medicine platform, this study will synchronously collect standard full-night polysomnography (PSG) data, continuous body-temperature data, smart-ring sensor data, contactless sleep-monitoring belt data, and indoor environmental monitoring data from the same participant during the same monitoring night. A clinical sleep database will be established with PSG-derived reference-standard labels, strict temporal synchronization, and multimodal features. The database will support the development, optimization, and validation of sleep-staging and obstructive sleep apnea (OSA)-screening models and will provide a data and modeling foundation for subsequent smart sleep-monitoring products, home-based sleep-health management, and clinically assisted screening applications.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-08-07

Completion Date

2026-12-31

Last Updated

2026-10-30

Healthy Volunteers

Yes

Conditions

Sleep Apnea, Obstructive Sleep Staging Screening

Inclusion Criteria: * Study Population 1: Individuals scheduled to undergo standard full-night PSG at a participating center. Participants must meet all of the following criteria: 1. Aged 18-65 years, of either sex. 2. Voluntarily agrees to participate and provides written informed consent. 3. Able to complete standard full-night attended Type I PSG. 4. Able to wear a smart ring and a continuous body-temperature patch and to use a contactless sleep-monitoring belt concurrently during PSG. 5. Able to complete study-related questionnaires and collection of basic information. Study Population 2: Recruited healthy volunteers or volunteers at low risk for sleep disorders. Participants must meet all of the following criteria: 1. Aged 18-65 years, of either sex. 2. Self-reports generally good sleep and no prominent subjective sleep complaints, such as habitual snoring, frequent awakenings with choking or gasping, chronic difficulty initiating or maintaining sleep, or excessive daytime sleepiness; and has no previous clinical diagnosis of sleep apnea, chronic insomnia, or any other sleep disorder. 3. Has not regularly used sedative-hypnotic medication during the previous month. 4. Voluntarily agrees to participate and provides written informed consent. 5. Able to complete standard full-night attended Type I PSG. 6. Able to wear a smart ring and a continuous body-temperature patch and to use a contactless sleep-monitoring belt concurrently during PSG. 7. Able to complete study-related questionnaires and collection of basic information. Exclusion Criteria: * A participant meeting any of the following criteria will be excluded: 1. Unable to complete full-night PSG. 2. Unable to wear or use the study devices, or has clear intolerance to the devices or adhesive materials. 3. Requires continuous positive airway pressure (CPAP), noninvasive ventilation, supplemental oxygen, or another medical device during the night that may significantly interfere with signal acquisition from PSG or the study devices. 4. Has persistent atrial fibrillation, a severe or unstable medical condition, significant organ dysfunction, or any condition that substantially affects sleep. 5. Has severe cognitive impairment, psychiatric or behavioral abnormalities, or another condition that prevents understanding of the study or cooperation with study procedures. 6. Is considered by the investigator to be unsuitable for completion of overnight monitoring. 7. Has any other condition that, in the investigator's judgment, makes participation inappropriate.

Locations (1)

Peking University First Hospiatl

Beijing, Beijing Municipality, China