Mucosal Inflammation in Children With OSA

Mucosal Inflammation in Children With OSA - Potential Biomarkers of OSA Complications

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06452979

Enrollment

110

Registered

2024-06-11

Start date

2023-01-01

Completion date

2025-12-31

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Years to 11 Years

Healthy volunteers

Yes

Inclusion criteria

* Children aged 6-11 years old

Exclusion criteria

* Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, suspected or confirmed congenital or acquired immunodeficiency, obesity (BMI z-score ≥1.645), 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.

Design outcomes

Primary

Measure	Time frame	Description
Inflammatory profile in the nasal fluid	3 years	Profile of inflammatory biomarkers in the nasal epithelial lining fluid: cytokines profiles

Secondary

Measure	Time frame	Description
Inflammatory profile in the peripheral blood	3 years	Systemic inflammatory biomarkers collected from peripheral blood: cytokines profiles

Countries

Hong Kong

Contacts

Primary ContactKate Ching Ching Chan, MD

katechan@cuhk.edu.hk35053515

Outcome results