Obstructive Sleep ApneaNCT06452992
Microbiome and Metabolomics Profiling in Children With OSA
An observational study of Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 130 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who attend the Paediatric Respiratory and Sleep Clinic at the Prince of Wales Hospital (PWH) for suspected OSA
Who may be able to join
- Children aged 6-11 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Kate Ching Ching Chan, MD, 35053515, katechan@cuhk.edu.hk
Kate Ching Ching Chan, MD
About this study
Official title: Microbiome and Metabolomics Profiling in Children With Obstructive Sleep Apnoea
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.
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.
Read more
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.
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool microbiome profiles
Stool microbiome profiles in children with OSA compared to non-OSA controls: MetaPhlAn3 profiles and functional profiling by Functional profiling by HUMAnN3
Measured: 2 years
Urine metabolomic profiles
Urine metabolomic profiles in children with OSA compared to non-OSA controls: hydrophilic and ionic metabolites, lipophilic metabolites
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Ching Ching Chan, Chinese University of Hong Kong
- Investigators
- Kate Ching Ching Chan, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452992
- Sponsor's protocol ID
- MOSAMM
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Metabolomics Profiling in Children With Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT06452992
- Acronym / sponsor ID
- MOSAMM
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who attend the Paediatric Respiratory and Sleep Clinic at the Prince of Wales Hospital (PWH) for suspected OSA
Key inclusion criteria (1 listed)
- Children aged 6-11 years old
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stool microbiome profiles
Time frame: 2 years
Stool microbiome profiles in children with OSA compared to non-OSA controls: MetaPhlAn3 profiles and functional profiling by Functional profiling by HUMAnN3
Urine metabolomic profiles
Time frame: 2 years
Urine metabolomic profiles in children with OSA compared to non-OSA controls: hydrophilic and ionic metabolites, lipophilic metabolites
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kate Ching Ching Chan, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Ching Ching Chan, MD (35053515, katechan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool microbiome profiles (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.