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NCT Number: NCT07736872

OSAHS Screening in Diverse 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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sign the informed consent form before participating in the study
  • Complete independent behaviour and cognitive abilities
  • Ability to answer the questionnaire completely and accurately

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Lowest Oxygen Saturation (Lowest SpO₂)

    Time frame: Baseline

    Collected from PSG or PM to evaluate nocturnal hypoxemia. Unit of Measure: %

Secondary outcomes

  1. Diagnostic Value of the CNCQ-OSA Questionnaire

    Time frame: Baseline

    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: %

  2. Diagnostic Value of the STOP-Bang Questionnaire

    Time frame: Baseline

    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: %

  3. Diagnostic Value of the NoSAS Score

    Time frame: Baseline

    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: %

Study contacts

Contact information is provided by the study sponsor or research team.

Donghao Wang, Phd

CONTACT

[email protected]

+86 15622204731

Dongxing Zhao, professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Kang Wu

Other

Registry information

Official study title

Screening for Obstructive Sleep Apnea-hypopnea Syndrome - for Community Populations, Patients With Specific Diseases and Special Populations

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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