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Microbiome and Metabolomics Profiling in Children With OSA

Key facts

Who runs it
Chinese University of Hong Kong
Where
Hong Kong, Hong KongSee the site
Trial code
Status
Recruiting
People taking part
130 people, planned
Started
1 Jul 2023
Expected to end
30 Jun 2027
Type of study
Observational, 2 groups
Record updated
21 October 2026

Who can take part

Age
6 years to 11 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

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Who can take part

  • Children aged 6-11 years old

Who cannot take part

  • Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, suspected or confirmed congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities, structural or congenital heart disease, use of medications or therapy that could affect immunity such as systemic corticosteroids, chemotherapy, radiation therapy, intravenous immunoglobulins

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 11 years old?

Where in Hong Kong

  • Prince of Wales HospitalHong Kong, Hong KongContact: Kate Ching Ching Chan, MDTaking people

About the trial

What the trial wants to find out

Objectives: Obstructive sleep apnoea (OSA) exhibits variable susceptibility to end-organ morbidities. Previous studies suggest that physiological sequelae in individuals with OSA promote changes in microbiome, which also interact with metabolic and inflammatory mediators. Therefore, microbiome and metabolomic profiling could potentially reveal the pathological processes underlying OSA. The primary objectives of our study are 1)To investigate the differences in the composition of nasal and stool microbiome between children with OSA and non-OSA controls; 2)To investigate the differences in the urine metabolomic profiles between children with OSA and non-OSA controls.

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Hypothesis to be tested: The microbiome composition and urine metabolomic profiles are different between children with OSA and non-OSA controls. Changes in microbiome composition are associated with specific urine metabolomic and inflammatory profiles in children with OSA.

Design and subjects: A prospective case-control study. Chinese children aged 6-11 years old with habitual snoring and polysomnography (PSG) confirmed OSA will be recruited as cases. Non-OSA healthy children will be recruited as controls. All subjects will undergo evaluation including questionnaires, anthropometric measurements, PSG, blood, urine, nasal and stool sampling.

Primary outcome measures: Microbiome and metabolomic profiles in children with OSA compared to non-OSA controls.

Analysis: Comparisons of the microbiome and metabolomic profiles between OSA children and controls. Correlations of microbiome and metabolomic profiles with inflammatory biomarkers and PSG measurements will be evaluated by regression analysis.

Expected results: This study will provide novel data regarding microbiome and metabolomic profiles, and their relationship with inflammatory biomarkers in children with OSA.

The 2 groups in the trial

  • Cases

    Children aged 6-11 years old with habitual snoring (≥3 nights per week) and PSG confirmed OSA (OAHI of ≥1/hour)

  • Controls

    Age, sex and BMI matched non-OSA control with PSG confirmed absence of OSA (OAHI \< 1 event/h)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Microbiome and Metabolomics Profiling in Children With Obstructive Sleep Apnoea
Fit questions
Built from NCT06452992, who can take part
Record updated
21 October 2026