Sleep Apnea, ObstructiveNCT06573372
Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by Peking University First Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 377 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected OSA patients, scheduled for polysomnography (PSG)
Who may be able to join
- Age ≥ 18 years; Suspected OSA, scheduled for polysomnography (PSG) Have signed informed consent form.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Validation Study on the Assessment of Sleep Apnea by Smart Watch and Smartphone
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while wearing a smartwatch and smartphone for monitoring. The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA.
Read the detailed description
OSA is common frequently-occurring disease, in the general population prevalence of 9% to 38%[2] (in apnea hypoventilation index (AHI) 5 for the standard or higher). A OSA, according to the global burden of global nearly 1 billion patients with OSA, and our country is, the most populous country[3] in the OSA sick: on the basis of AHI 5 or more, China has 176 million OSA crowd; With AHI ≥15 as the standard, China has 66 million people with OSA. Although the high prevalence of OSA, diagnostic rate was very low, a study shows there are now about 90% of undiagnosed[4] OSA. The serious influence the diagnosis and treatment of OSA and downstream disease prevention and control.
There are many reasons for the low diagnosis rate of OSA. About the danger of OSA patients with insufficient understanding and OSA diagnosis treatment process link is the more important reason. The OSA diagnosis depends on the patient to the hospital, after outpatient service initiated or portable polysomnography evaluation, limited by registered, see a doctor, make an appointment, monitoring, and many other processes, as well as the level of understanding of OSA patients, many patients with OSA don't want to come to the hospital. With the popularity of intelligent wearable devices, intelligent wearable device can effectively monitor the human multiple physiological indicators, and has high comfort, the cost is low, the detection process is not restricted by time and place, etc. Besides smartphones by smart sensors, collect the snoring, heart shock signals (BCG) and respiratory, physiological parameters, such as non-contact multi-parameter sleep monitoring technology, made possible by the. These are the home sleep monitoring way to provide more convenient and easy to use, makes the risk of OSA screening more convenient[5-8].
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while wearing a smartwatch and smartphone for monitoring. The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA.
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep Apnea, Obstructive, smart watch, smartphone, Apnea-Hypopnea Index
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic specificity, sensitivity
The diagnostic specificity, sensitivity of OPPO smartphone and smartwatch
Measured: 29/8/2024-31/7/2026
Secondary outcomes (1)
apnea-hypopnea index (AHI)
The accuracy of apnea-hypopnea index (AHI) determined by smart watch and smartphones were compared with polysomnography (PSG) .
Measured: 29/8/2024-31/7/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start29 Aug 2024
- Primary completion30 May 2025
- Study completion31 May 2025
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.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- OPPO
- Responsible party
- Principal investigator, Jing MA, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573372
- Sponsor's protocol ID
- 2024 Research 347-001
- Status last verified
- Jul 2026
- First submitted
- 24 Aug 2024
- Last updated
- 14 Jul 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Validation Study on the Assessment of Sleep Apnea by Smart Watch and Smartphone
- ClinicalTrials.gov ID
- NCT06573372
- Acronym / sponsor ID
- 2024 Research 347-001
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep Apnea, Obstructive, smart watch, smartphone, Apnea-Hypopnea Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- OPPO
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 27 Aug 2024 (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.
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while wearing a smartwatch and smartphone for monitoring. The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA.
Detailed description
OSA is common frequently-occurring disease, in the general population prevalence of 9% to 38%[2] (in apnea hypoventilation index (AHI) 5 for the standard or higher). A OSA, according to the global burden of global nearly 1 billion patients with OSA, and our country is, the most populous country[3] in the OSA sick: on the basis of AHI 5 or more, China has 176 million OSA crowd; With AHI ≥15 as the standard, China has 66 million people with OSA. Although the high prevalence of OSA, diagnostic rate was very low, a study shows there are now about 90% of undiagnosed[4] OSA. The serious influence the diagnosis and treatment of OSA and downstream disease prevention and control.
There are many reasons for the low diagnosis rate of OSA. About the danger of OSA patients with insufficient understanding and OSA diagnosis treatment process link is the more important reason. The OSA diagnosis depends on the patient to the hospital, after outpatient service initiated or portable polysomnography evaluation, limited by registered, see a doctor, make an appointment, monitoring, and many other processes, as well as the level of understanding of OSA patients, many patients with OSA don't want to come to the hospital. With the popularity of intelligent wearable devices, intelligent wearable device can effectively monitor the human multiple physiological indicators, and has high comfort, the cost is low, the detection process is not restricted by time and place, etc. Besides smartphones by smart sensors, collect the snoring, heart shock signals (BCG) and respiratory, physiological parameters, such as non-contact multi-parameter sleep monitoring technology, made possible by the. These are the home sleep monitoring way to provide more convenient and easy to use, makes the risk of OSA screening more convenient[5-8].
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while wearing a smartwatch and smartphone for monitoring. The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected OSA patients, scheduled for polysomnography (PSG)
Key inclusion criteria (1 listed)
- Age ≥ 18 years; Suspected OSA, scheduled for polysomnography (PSG) Have signed informed consent form.
Key exclusion criteria (1 listed)
- 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
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
diagnostic specificity, sensitivity
Time frame: 29/8/2024-31/7/2026
The diagnostic specificity, sensitivity of OPPO smartphone and smartwatch
1 secondary outcome
apnea-hypopnea index (AHI)
Time frame: 29/8/2024-31/7/2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic specificity, sensitivity (time frame: 29/8/2024-31/7/2026). 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 14 Jul 2026.