An observational study in Obstructive Sleep Apnea, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Chinese University of Hong Kong · Observational
Objectives: Variability of clinical phenotypes in childhood obstructive sleep apnoea (OSA) has prompted research for biomarkers to identify patients at risk of developing OSA-related complications. Upper airway inflammation is documented in children with OSA. Whether it is related to end-organ morbidities and systemic inflammation is under-explored. The primary objectives of our study are 1)To evaluate inflammatory biomarkers with the use of nasal epithelial lining fluid (NELF) collected by nasal strips as a representation of upper airway inflammation in children with OSA compared to non-OSA controls; 2) To evaluate the associations between NELF biomarkers with ambulatory blood pressure (ABP) outcomes in children with OSA.
Hypothesis to be tested: Inflammatory biomarkers in NELF in children with OSA are altered when compared with non-OSA controls and correlated with ABP outcomes.
Design and subjects: A prospective case-control study. Non-obese Chinese children aged 6-11 years old with habitual snoring (≥3 nights per week) and polysomnography (PSG) confirmed OSA (OAHI of ≥1/hour) will be recruited as cases. Non-OSA children with OAHI \< 1 event/h will be recruited as controls. All subjects will undergo evaluation including questionnaires, anthropometric measurements, PSG, 24-hour ABP measurement, blood and NELF sampling.
Primary outcome measure: Profile of inflammatory biomarkers in the NELF. Analysis: Correlations between NELF inflammatory biomarkers with polysomnographic and ABP measurements will be evaluated by regression analysis.
Expected results: This study will provide novel and important information regarding upper airway inflammatory biomarkers in children with OSA and their relationship with blood pressure outcomes.
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This study's planned enrollment of 110 is close to the median of 102 across 66 observational studies indexed under Mucositis.
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Chinese children aged 6-11 years old with symptoms suggestive of obstructive sleep apnoea and healthy controls.
Exclusion Criteria:
Children aged 6-11 years old with habitual snoring (≥3 nights per week) and PSG confirmed OSA (OAHI of ≥1/hour)
Non-OSA age, sex and BMI-matched control with PSG confirmed absence of OSA (OAHI \< 1 event/h)
Inflammatory profile in the nasal fluid
Profile of inflammatory biomarkers in the nasal epithelial lining fluid: cytokines profiles
Time frame: 3 years
Inflammatory profile in the peripheral blood
Systemic inflammatory biomarkers collected from peripheral blood: cytokines profiles
Time frame: 3 years
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Chinese University of Hong Kong