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临床试验/NCT03895775
NCT03895775招募中不适用

Prevalence of Obstructive Sleep Apnoea Among Adolescents in the General Population

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 740 人开始时间: 2019年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
740
试验地点
1
主要终点
Presence of obstructive sleep apnoea (OSA)

研究概览

简要总结

Obstructive sleep apnoea (OSA) is associated with a variety of important complications, namely cardiovascular, neurocognitive and metabolic disturbances. The prevalence of OSA is well studied in children and adults. However, adolescence - an interface between childhood and adulthood, and a period of developmental changes known to affect sleep is largely unexplored in relation to OSA. The only published prevalence study on adolescents is limited by its small sample size, not a true representation of the general population and primarily focused on Caucasians. In this proposal, the investigators aim to determine the prevalence of OSA, and associated clinical features in a population-based sample of adolescents aged between 12 and 16 years.

The sample selection will be based on a stratified (by districts) and clustered (subjects within randomly selected schools) randomised sampling frame. Each participant will fill in a sleep habit questionnaire, undergo anthropometric measurements, physical examination and complete home polysomnographic recordings. Participants will undergo Conners' Continuous Performance Test and have blood samples taken to phenotype their cardiovascular and metabolic risk. The primary outcome is prevalence of OSA, assessed by the obstructive apnoea hypopnoea index. Secondary outcomes include use of logistic regression models to assess association between different severities of OSA and various demographic, clinical and laboratory variables.

The obtained result will provide the much-needed OSA prevalence in adolescents which is essential for estimating the true burden of disease within this population. This information is also vital when considering population-based health policies and interventional strategies. Globally, the findings from currently evidence-sparse region of the world allow future international comparison of disease burden. Our study will also form a platform from which repeated measurements can be made to assess time trends and to answer the important question of whether adulthood OSA takes its origin from adolescence.

详细描述

Study Design

It is a cross-sectional, population-based study. Subjects who are found to meet all the inclusion and none of the exclusion criteria will be recruited. Participants will complete a set of sleep-related questionnaires, undergo anthropometric measurements, home polysomnographic (PSG) monitoring, attention assessment and phenotyping of their metabolic and cardiovascular risk.

Collection of Data The subjects will attend our unit for assessment and explanation of home PSG monitoring. After a 15-minute rest, systolic (SBP) and diastolic (DBP) blood pressure will be taken using the Datascope Accutorr Plus. Two measurements are taken at 1-minute intervals, with a third reading taken 5 minutes later if the difference between the first two >4 mmHg. The average of two repeatable readings (difference ≤4 mmHg) will be used. Anthropometric parameters including standing height (in metres) without shoes and body weight (in kilograms) will be recorded using Harpenden Stadiometer (Holtain, UK) and an electronic weighing scale (Tanita BF-522, Japan) respectively according to standard recommendations. Waist and hip circumference (in centimetres) will also be obtained. Neck circumference will be measured at the level of the most prominent portion of the thyroid cartilage with the head held erect and the eyes facing forward. Z scores of body mass index and waist circumference will be calculated using local references.

If the participating school is agreeable and logistically feasible, our research team can carry out the above at school. However, in our experience schools close to our unit prefer to send their students to us to undergo the various assessments.

All assessments will be carried out during the week to avoid weekday-weekend difference in adolescents' sleep pattern. The students will also complete a chronotype preference questionnaire, result from which can provide guidance regarding effects of sleep phase. The reduced version of Horne and Östberg Morningness-Eveningness Questionnaire (rMEQ) will be used to measure chronotype preference. It consists of five items designed to assess one's preferred bedtime and rise time, the degree of tiredness in the morning, peak time for optimal performance, and self-perceived circadian preference. The rMEQ has been validated in ethnic Chinese individuals, with good psychometric properties [36], and has been used in previous research conducted in adolescents.[37, 38] Participants scored higher than 17 and lower than 12 will be classified as morning-type and evening-type, respectively. Participants with total rMEQ scores between 12 and 17 will be classified as intermediate-type.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged 12-16 years
  • Written informed consent from parents and assent from participants available

排除标准

  • Previously undergone upper airway surgery or currently receiving treatment for OSA
  • Craniofacial anomalies
  • Unable to speak or read Chinese

结局指标

主要结局

Presence of obstructive sleep apnoea (OSA)

时间窗: Baseline

OSA is defined using different cut-offs (i.e. OAHI \>=5, OAHI \>=1, OAHI \>=1+habitual snoring)

次要结局

  • Impulsivity(Baseline)
  • Fasting blood glucose level(Baseline)
  • Leptin level(Baseline)
  • Adiponectin level(Baseline)
  • Vigilance(Baseline)
  • Triglyceride (TG) level(Baseline)
  • High sensitivity C-reactive protein (hs-CRP)(Baseline)
  • Ghrelin level(Baseline)
  • Total cholesterol level(Baseline)
  • High-density lipoprotein cholesterol (LDL-C) concentration(Baseline)
  • Tumour necrosis factor-α level(Baseline)
  • Low-density lipoprotein cholesterol (LDL-C) concentration(Baseline)
  • Interleukin-6(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Albert Martin Li

Prof

Chinese University of Hong Kong

研究点 (1)

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