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OSAHS Screening in Diverse Populations

26. juli 2026 oppdatert av: Kang Wu

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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  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.

Studietype

Observasjonsmessig

Registrering (Antatt)

100000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Donghao Wang, Phd
  • Telefonnummer: +86 15622204731
  • E-post: 820512548@qq.com

Studer Kontakt Backup

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • The First Affiliated Hospital of Guangzhou Medical University
        • Ta kontakt med:
    • Guizhou
      • Anshun, Guizhou, Kina
        • Har ikke rekruttert ennå
        • Anshun People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: 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.
special population
Including college teachers and students, doctors and nurses, and company employees, aged 18-80 years old.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Apnea-Hypopnea Index (AHI)
Tidsramme: Baseline
Collected from polysomnography (PSG) or home sleep apnea testing (PM) for the diagnosis of obstructive sleep apnea (OSA). Unit of Measure: events/hour
Baseline
Lowest Oxygen Saturation (Lowest SpO₂)
Tidsramme: Baseline
Collected from PSG or PM to evaluate nocturnal hypoxemia. Unit of Measure: %
Baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic Value of the CNCQ-OSA Questionnaire
Tidsramme: 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: %
Baseline
Diagnostic Value of the STOP-Bang Questionnaire
Tidsramme: 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: %
Baseline
Diagnostic Value of the NoSAS Score
Tidsramme: 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: %
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kang Wu

Etterforskere

  • Studieleder: Nuofu Zhang, professor, The First Affiliated Hospital of Guangzhou Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2024

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

6. juni 2025

Først innsendt som oppfylte QC-kriteriene

26. juli 2026

Først lagt ut (Faktiske)

30. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ES-2024-169-01
  • 202201020586 (Annet stipend/finansieringsnummer: Guangzhou Science and Technology Bureau)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

all IPD that underlie results in a publication

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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