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RecruitingNCT07908160Updated Oct 30, 2026

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

An observational study in Sleep Apnea, Obstructive, Sleep Staging and Screening, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Peking University First Hospital · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Oct 30, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Apnea, Obstructive
  • Sleep Staging
  • Screening
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Study Population 1: Individuals scheduled to undergo standard full-night PSG at a participating center.

Study Population 2: Recruited healthy volunteers or volunteers at low risk for sleep disorders. Participants

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The sensitivity and specificity of the OSA-screening model

    Taking polysomnography (PSG) as the gold standard, to evaluate the specificity and sensitivity of a new OSA diagnostic system for OSA diagnosis.

    Time frame: August 2026 to August 2027

  2. The Cohen's kappa coefficient and overall accuracy of Sleep-staging model

    Agreement and accuracy of sleep stage scoring by the new OSA monitoring system versus PSG (gold standard)

    Time frame: August 2026 to August 2027

Secondary outcomes

  1. Stage-specific classification performance of the AI(artifical intelligence) model:precision, recall, and F1 score for each sleep stage.

    Time frame: August 2026 to August 2027

  2. Overall accuracy of the OSA-screening model, area under the receiver operating characteristic curve (AUC), and the corresponding 95% confidence interval (CI).

    Time frame: August 2026 to August 2027

  3. Exploratory associations of clinical characteristics, subjective scales, body-temperature rhythms, and environmental parameters with PSG-derived sleep architecture and respiratory events.

    Time frame: August 2026 to August 2027

  4. Incidence of discomfort related to device wear and other adverse events.

    Time frame: August 2026 to August 2027

07

Study locations

1 of 1 sites recruiting
  • Peking University First Hospiatl
    Beijing, Beijing Municipality 100034, China
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07908160
Collaborators
Beijing Jinriyixiu Technology Co., Ltd.
Responsible party
Jing MA (Prof., Peking University First Hospital) — Principal investigator
First posted
Oct 30, 2026
Start date
Aug 7, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 30, 2026

Study contacts

Cheng Zhang, Dr.
Contact
zhangcheng033@163.com
86-10-13611035724

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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