Obstructive Sleep Apnea (OSA)NCT07736872
OSAHS Screening in Diverse Populations
An observational study of Obstructive Sleep Apnea (OSA) and Snoring, run by Kang Wu at 2 sites in China.
Trial summary
The goal of this prospective observational study is to learn about the current prevalence of obstructive sleep apnea-hypopnea syndrome in community population, patients with specific diseases and special population from China. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Snoring, Prevalence
- What is being tested?
- patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities.
- How many people
- 100,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2024to 1 Aug 2027
- How long will I take part?
- 2 Days
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Target participants were recruited from multiple centers: Community population: A random number table method is used to select several communities within the designated research area. The research team then obtains a complete list of registered residents in these communities as the sampling frame. A computer-based random number generator is utilized to randomly select target residents. Patients with specific diseases: hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities. Special population: Including college teachers and students, doctors and nurses, and company employees.
Who may be able to join
- Sign the informed consent form before participating in the study
- Complete independent behaviour and cognitive abilities
- Ability to answer the questionnaire completely and accurately
Who cannot join
- Incomplete answers to the scale
- Patients with severe diseases and acute infections or those requiring long-term home oxygen therapy
- Patients with severe mental and psychological disorders
- Patients with severe organ failure
- patients with a total sleep time <240 min by PSG or PM
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dongxing Zhao, professor contact
China2 sites, 2 recruiting
- Not yet recruiting
Anshun People's Hospital
Anshun, Guizhou
Wenqu Liu, +86 13765318077, rieast@163.com
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Donghao Wang, Phd, +86 15622204731, 820512548@qq.com
About this study
Official title: Screening for Obstructive Sleep Apnea-hypopnea Syndrome - for Community Populations, Patients With Specific Diseases and Special Populations
The goal of this prospective observational study is to learn about the current prevalence of obstructive sleep apnea-hypopnea syndrome in community population, patients with specific diseases and special population from China. The main question it aims to answer is: (1) What are the prevalence and clinical characteristics of OSA in the community population, the specific disease population and the special population respectively? (2) How about the application value of each OSA screening questionnaire for different populations？Participants will all complete a screening questionnaire, and some will be selected by random sampling to complete either a polysomnography (PSG) or a portable sleep monitor (PM).
Read the detailed description
- This is a multi-center study spans China, engaging many hospitals and research institutions. It involves community residents, patients with hypertension, COPD, and other specific diseases, as well as special populations like university teachers and students, and company employees. The study is still recruiting and 2,185 subjects have been included currently.
- This study employs rigorous randomization methods to ensure the representativeness of the sample and the reliability of the results. For community residents, cluster sampling is first applied. A random number table method is used to select several communities within the designated research area. The research team then obtains a complete list of registered residents in these communities as the sampling frame. A computer-based random number generator is utilized to randomly select target residents. Those selected are contacted by telephone for the screening questionnaire. If telephone contact fails, interviewers visit the residents' homes to conduct the survey, ensuring every selected resident has an equal chance of participation.
- For individuals categorized into OSA high - risk and low - risk groups based on the screening questionnaire, computer - based numbering and randomization are used. Specifically, the information of individuals in each group is entered into a computer system, which assigns a unique number to each individual. Random number - generation software then produces a random sequence of numbers. Individuals are selected for subsequent PSG or PM based on this sequence. This method ensures the scientific and unbiased selection of the sample.
- The sample size is determined based on OSA's expected prevalence (23.6%). To estimate the 95% confidence interval with a 5% precision level, at least 277 participants are needed for diagnostic monitoring. Considering a 30% dropout rate and an 80% response rate for the screening questionnaire, the total sample size is set at 100,000 for questionnaires and 10,000 for PSG or PM.
- Missing data will be handled through multiple imputation. The reasons for missing data are recorded, and sensitivity analyses assess its impact on results. Data checks verify that entries meet predefined rules for range and consistency, identifying and correcting anomalies promptly.
- SOPs cover all aspects of registry operations, ensuring consistency and quality in data collection and management. All questionnaires were manually entered into the electronic system. The reports of PSG or PM were manually interpreted by two professional sleep physicians. In case of disputes, a third person was invited to intervene.
- Being tested
- patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities.
- Keywords
- osbtructive sleep apnea, snoring, prevalence, screening questionnaires, CNCQ-OSA, STOP-Bang, NoSAS
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities.Other
In order to explore the prevalence of OSA in patients with different comorbid diseases, this study set up this observation group.
| Study group | Role | What they receive |
|---|---|---|
| community population | registered community populations aged 18-80 years old. | |
| patients with specific diseases | patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities, aged 18-80 years old. Receives: Other: patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities. | |
| special population | Including college teachers and students, doctors and nurses, and company employees, aged 18-80 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Collected from polysomnography (PSG) or home sleep apnea testing (PM) for the diagnosis of obstructive sleep apnea (OSA). Unit of Measure: events/hour
Measured: Baseline
Lowest Oxygen Saturation (Lowest SpO₂)
Collected from PSG or PM to evaluate nocturnal hypoxemia. Unit of Measure: %
Measured: Baseline
Secondary outcomes (3)
Diagnostic Value of the CNCQ-OSA Questionnaire
Based on the PSG/PM results as the reference standard, the diagnostic accuracy of the Obstructive Sleep Apnea Screening Questionnaire for Chinese Community (CNCQ-OSA) will be evaluated. The outcome measures include sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy rate. Unit of Measure: %
Measured: Baseline
Diagnostic Value of the STOP-Bang Questionnaire
Based on the PSG/PM results as the reference standard, the diagnostic accuracy of the STOP-Bang questionnaire will be evaluated. The outcome measures include sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy rate. Unit of Measure: %
Measured: Baseline
Diagnostic Value of the NoSAS Score
Based on the PSG/PM results as the reference standard, the diagnostic accuracy of the Neck circumference, Obesity, Snoring, Age, Sex (NoSAS) score will be evaluated. The outcome measures include sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy rate. Unit of Measure: %
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Kang Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kang Wu, Guangzhou Institute of Respiratory Disease
- Investigators
- Nuofu Zhang, professor, Study director, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736872
- Sponsor's protocol ID
- ES-2024-169-01
- Other IDs
- 202201020586
- Status last verified
- Jul 2026
- First submitted
- 6 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Obstructive Sleep Apnea-hypopnea Syndrome - for Community Populations, Patients With Specific Diseases and Special Populations
- ClinicalTrials.gov ID
- NCT07736872
- Acronym / sponsor ID
- ES-2024-169-01
- Keywords
- osbtructive sleep apnea, snoring, prevalence, screening questionnaires, CNCQ-OSA, STOP-Bang, NoSAS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Kang WuUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 30 Jul 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.
The goal of this prospective observational study is to learn about the current prevalence of obstructive sleep apnea-hypopnea syndrome in community population, patients with specific diseases and special population from China. The main question it aims to answer is: (1) What are the prevalence and clinical characteristics of OSA in the community population, the specific disease population and the special population respectively? (2) How about the application value of each OSA screening questionnaire for different populations？Participants will all complete a screening questionnaire, and some will be selected by random sampling to complete either a polysomnography (PSG) or a portable sleep monitor (PM).
Detailed description
- This is a multi-center study spans China, engaging many hospitals and research institutions. It involves community residents, patients with hypertension, COPD, and other specific diseases, as well as special populations like university teachers and students, and company employees. The study is still recruiting and 2,185 subjects have been included currently.
- This study employs rigorous randomization methods to ensure the representativeness of the sample and the reliability of the results. For community residents, cluster sampling is first applied. A random number table method is used to select several communities within the designated research area. The research team then obtains a complete list of registered residents in these communities as the sampling frame. A computer-based random number generator is utilized to randomly select target residents. Those selected are contacted by telephone for the screening questionnaire. If telephone contact fails, interviewers visit the residents' homes to conduct the survey, ensuring every selected resident has an equal chance of participation.
- For individuals categorized into OSA high - risk and low - risk groups based on the screening questionnaire, computer - based numbering and randomization are used. Specifically, the information of individuals in each group is entered into a computer system, which assigns a unique number to each individual. Random number - generation software then produces a random sequence of numbers. Individuals are selected for subsequent PSG or PM based on this sequence. This method ensures the scientific and unbiased selection of the sample.
- The sample size is determined based on OSA's expected prevalence (23.6%). To estimate the 95% confidence interval with a 5% precision level, at least 277 participants are needed for diagnostic monitoring. Considering a 30% dropout rate and an 80% response rate for the screening questionnaire, the total sample size is set at 100,000 for questionnaires and 10,000 for PSG or PM.
- Missing data will be handled through multiple imputation. The reasons for missing data are recorded, and sensitivity analyses assess its impact on results. Data checks verify that entries meet predefined rules for range and consistency, identifying and correcting anomalies promptly.
- SOPs cover all aspects of registry operations, ensuring consistency and quality in data collection and management. All questionnaires were manually entered into the electronic system. The reports of PSG or PM were manually interpreted by two professional sleep physicians. In case of disputes, a third person was invited to intervene.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| community population | – | –registered community populations aged 18-80 years old. |
| patients with specific diseases | – | Other: patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities.patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities, aged 18-80 years old. |
| special population | – | –Including college teachers and students, doctors and nurses, and company employees, aged 18-80 years old. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Target participants were recruited from multiple centers: Community population: A random number table method is used to select several communities within the designated research area. The research team then obtains a complete list of registered residents in these communities as the sampling frame. A computer-based random number generator is utilized to randomly select target residents. Patients with specific diseases: hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities. Special population: Including college teachers and students, doctors and nurses, and company employees.
Key inclusion criteria (3 listed)
- Sign the informed consent form before participating in the study
- Complete independent behaviour and cognitive abilities
- Ability to answer the questionnaire completely and accurately
Key exclusion criteria (5 listed)
- Incomplete answers to the scale
- Patients with severe diseases and acute infections or those requiring long-term home oxygen therapy
- Patients with severe mental and psychological disorders
- Patients with severe organ failure
- patients with a total sleep time <240 min by PSG or PM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities.In order to explore the prevalence of OSA in patients with different comorbid diseases, this study set up this observation group. | Other | patients with specific diseases |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: Baseline
Collected from polysomnography (PSG) or home sleep apnea testing (PM) for the diagnosis of obstructive sleep apnea (OSA). Unit of Measure: events/hour
Lowest Oxygen Saturation (Lowest SpO₂)
Time frame: Baseline
Collected from PSG or PM to evaluate nocturnal hypoxemia. Unit of Measure: %
3 secondary outcomes
Diagnostic Value of the CNCQ-OSA Questionnaire
Time frame: Baseline
Diagnostic Value of the STOP-Bang Questionnaire
Time frame: Baseline
Diagnostic Value of the NoSAS Score
Time frame: Baseline
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 Jul 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Dongxing Zhao, professor contact
Nuofu Zhang, professor study director
The First Affiliated Hospital of Guangzhou Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and Snoring, run by Kang Wu at 2 sites 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 3 inclusion and 5 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 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 2 sites 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 Donghao Wang, Phd (+86 15622204731, 820512548@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: Baseline). 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 Jul 2026.