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Recruiting NCT07736872

OSAHS Screening in Diverse Populations

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities..
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea (OSA), Snoring, Prevalence, Questionnaires and Surveys. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other 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.

Primary outcome measures

  • Apnea-Hypopnea Index (AHI) [Time frame: Baseline]
  • Lowest Oxygen Saturation (Lowest SpO₂) [Time frame: Baseline]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Ecologic or community

Study locations

China · 2 centers
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Anshun People's Hospital — Anshun

Identifiers

NCT: NCT07736872 · ES-2024-169-01 · 202201020586

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗