Obstructive Sleep Apnea Clinical Trial
Official title:
Prevalence of Obstructive Sleep Apnoea Among Adolescents in the General Population
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.
Status | Recruiting |
Enrollment | 740 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 16 Years |
Eligibility | Inclusion Criteria: 1. Adolescents aged 12-16 years 2. Written informed consent from parents and assent from participants available Exclusion Criteria: 1. Previously undergone upper airway surgery or currently receiving treatment for OSA 2. Craniofacial anomalies 3. Unable to speak or read Chinese |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Paediatrics, The Chinese University of Hong Kong | Sha Tin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of obstructive sleep apnoea (OSA) | OSA is defined using different cut-offs (i.e. OAHI >=5, OAHI >=1, OAHI >=1+habitual snoring) | Baseline | |
Secondary | Vigilance | Measured by Conners' Continuous Performance Test (CPT) | Baseline | |
Secondary | Impulsivity | Measured by Conners' Continuous Performance Test (CPT) | Baseline | |
Secondary | Fasting blood glucose level | Blood sample will be taken from the subjects for fasting (at least 8 hours). Plasma glucose is measured by hexokinase method. | Baseline | |
Secondary | Total cholesterol level | TC will be measured by an appropriate enzymatic assay | Baseline | |
Secondary | Triglyceride (TG) level | TG will be measured by an appropriate enzymatic assay | Baseline | |
Secondary | High-density lipoprotein cholesterol (LDL-C) concentration | HDL-C will be measured by an appropriate enzymatic assay | Baseline | |
Secondary | Low-density lipoprotein cholesterol (LDL-C) concentration | LDL-C will be measured by an appropriate enzymatic assay | Baseline | |
Secondary | High sensitivity C-reactive protein (hs-CRP) | Serum hs-CRP will be measured by chemiluminescence immunoassay using the IMMULITE Analyzer | Baseline | |
Secondary | Ghrelin level | This appetite-regulating hormone will be measured using Enzyme-Linked Immunosorbent Assay. | Baseline | |
Secondary | Leptin level | This appetite-regulating hormone will be measured using Enzyme-Linked Immunosorbent Assay. | Baseline | |
Secondary | Adiponectin level | This appetite-regulating hormone will be measured using Enzyme-Linked Immunosorbent Assay. | Baseline | |
Secondary | Tumour necrosis factor-a level | This proinflammatory cytokine will be measured using Enzyme-Linked Immunosorbent Assay. | Baseline | |
Secondary | Interleukin-6 | This proinflammatory cytokine will be measured using Enzyme-Linked Immunosorbent Assay. | Baseline |
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