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Идёт набор NCT07736872

OSAHS Screening in Diverse Populations

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: patients with hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic obstructive pulmonary disease, asthma and other OSA related comorbidities..
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea (OSA), Snoring, Prevalence, Questionnaires and Surveys. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Apnea-Hypopnea Index (AHI) [Срок оценки: Baseline]
  • Lowest Oxygen Saturation (Lowest SpO₂) [Срок оценки: Baseline]
Вторичные конечные точки (3)
  • Diagnostic Value of the CNCQ-OSA Questionnaire [Срок оценки: Baseline]
  • Diagnostic Value of the STOP-Bang Questionnaire [Срок оценки: Baseline]
  • Diagnostic Value of the NoSAS Score [Срок оценки: Baseline]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Экологическое

Центры проведения

Китай · 2 центра
  • The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
  • Anshun People's Hospital — Anshun

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗