Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452979
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-11-01
Brief Title:
Mucosal Inflammation in Children With OSA
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Mucosal Inflammation in Children With OSA - Potential Biomarkers of OSA Complications
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 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 1To 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 1hour will be recruited as cases Non-OSA children with OAHI 1 eventh 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
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 1hour will be recruited as cases Non-OSA children with OAHI 1 eventh 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
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