Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452992
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-11-01
Brief Title:
Microbiome and Metabolomics Profiling in Children With OSA
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Microbiome and Metabolomics Profiling in Children With Obstructive Sleep Apnoea
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Therefore microbiome and metabolomic profiling could potentially reveal the pathological processes underlying OSA The primary objectives of our study are 1To investigate the differences in the composition of nasal and stool microbiome between children with OSA and non-OSA controls 2To 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None