Sleep Apnea, ObstructiveNCT07908160
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 of Sleep Apnea, Obstructive and Sleep Staging, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Sleep Staging, Screening
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Study Population 1: Individuals scheduled to undergo standard full-night PSG at a participating center.
- Participants must meet all of the following criteria:
- Aged 18-65 years, of either sex.
- Voluntarily agrees to participate and provides written informed consent.
- Able to complete standard full-night attended Type I PSG.
- Able to wear a smart ring and a continuous body-temperature patch and to use a contactless sleep-monitoring belt concurrently during PSG.
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- 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:
- Aged 18-65 years, of either sex.
- 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.
- Has not regularly used sedative-hypnotic medication during the previous month.
- Voluntarily agrees to participate and provides written informed consent.
- Able to complete standard full-night attended Type I PSG.
- Able to wear a smart ring and a continuous body-temperature patch and to use a contactless sleep-monitoring belt concurrently during PSG.
- Able to complete study-related questionnaires and collection of basic information.
Who cannot join
- A participant meeting any of the following criteria will be excluded:
- Unable to complete full-night PSG.
- Unable to wear or use the study devices, or has clear intolerance to the devices or adhesive materials.
- 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.
- Has persistent atrial fibrillation, a severe or unstable medical condition, significant organ dysfunction, or any condition that substantially affects sleep.
- Has severe cognitive impairment, psychiatric or behavioral abnormalities, or another condition that prevents understanding of the study or cooperation with study procedures.
- Is considered by the investigator to be unsuitable for completion of overnight monitoring.
- Has any other condition that, in the investigator's judgment, makes participation inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospiatl
Beijing, Beijing Municipality, 100034
Cheng Zhang, zhangcheng033@163.com
About this study
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.
- Conditions
- Sleep Apnea, Obstructive, Sleep Staging, Screening
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: August 2026 to August 2027
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)
Measured: August 2026 to August 2027
Secondary outcomes (4)
Stage-specific classification performance of the AI（artifical intelligence） model:precision, recall, and F1 score for each sleep stage.
Measured: August 2026 to August 2027
Overall accuracy of the OSA-screening model, area under the receiver operating characteristic curve (AUC), and the corresponding 95% confidence interval (CI).
Measured: August 2026 to August 2027
Exploratory associations of clinical characteristics, subjective scales, body-temperature rhythms, and environmental parameters with PSG-derived sleep architecture and respiratory events.
Measured: August 2026 to August 2027
Incidence of discomfort related to device wear and other adverse events.
Measured: August 2026 to August 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start7 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jinriyixiu Technology Co., Ltd.
- Responsible party
- Principal investigator, Jing MA, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908160
- Sponsor's protocol ID
- 2026R0412
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07908160
- Acronym / sponsor ID
- 2026R0412
- Conditions
- Sleep Apnea, Obstructive, Sleep Staging, Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Beijing Jinriyixiu Technology Co., Ltd.
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (15 listed)
- Study Population 1: Individuals scheduled to undergo standard full-night PSG at a participating center.
- Aged 18-65 years, of either sex.
- Voluntarily agrees to participate and provides written informed consent.
- Able to complete standard full-night attended Type I PSG.
- Able to wear a smart ring and a continuous body-temperature patch and to use a contactless sleep-monitoring belt concurrently during PSG.
Key exclusion criteria (8 listed)
- A participant meeting any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sensitivity and specificity of the OSA-screening model
Time frame: August 2026 to August 2027
Taking polysomnography (PSG) as the gold standard, to evaluate the specificity and sensitivity of a new OSA diagnostic system for OSA diagnosis.
The Cohen's kappa coefficient and overall accuracy of Sleep-staging model
Time frame: August 2026 to August 2027
Agreement and accuracy of sleep stage scoring by the new OSA monitoring system versus PSG (gold standard)
4 secondary outcomes
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
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
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
Incidence of discomfort related to device wear and other adverse events.
Time frame: August 2026 to August 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Sleep Staging, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng Zhang, Dr. (86-10-13611035724, zhangcheng033@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of the OSA-screening model (time frame: August 2026 to August 2027). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.