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OSAHS Screening in Diverse Populations

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07736872
Enrollment
100000
Registered
2026-07-30
Start date
2024-09-01
Completion date
2027-08-01
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA), Prevalence, Questionnaires and Surveys, Snoring

Keywords

osbtructive sleep apnea, snoring, prevalence, screening questionnaires, CNCQ-OSA, STOP-Bang, NoSAS

Brief 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. 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

1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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.

Interventions

OTHERpatients 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.

Sponsors

Kang Wu
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Apnea-Hypopnea Index (AHI)BaselineCollected 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)BaselineCollected from PSG or PM to evaluate nocturnal hypoxemia. Unit of Measure: %

Secondary

MeasureTime frameDescription
Diagnostic Value of the CNCQ-OSA QuestionnaireBaselineBased 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: %
Diagnostic Value of the STOP-Bang QuestionnaireBaselineBased 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: %
Diagnostic Value of the NoSAS ScoreBaselineBased 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: %

Countries

China

Contacts

CONTACTDonghao Wang, Phd
820512548@qq.com+86 15622204731
CONTACTDongxing Zhao, professor
rieast@163.com
STUDY_DIRECTORNuofu Zhang, professor

The First Affiliated Hospital of Guangzhou Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026