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Endothelial Dysfunction and Oxidative Stress in Children With Sleep Disordered Breathing.

NCT02247167 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-09-23

No results posted yet for this study

Summary

Sleep disordered breathing (SDB) is a common disease in both adults and children and is caused by the obstruction of the upper airway during sleep. Unlike adults, most cases of paediatric SDB are due to the presence of enlarged tonsils and adenoids, thus the main treatment option is adenotonsillectomy (AT). It is well known that obstructive sleep apnoea (OSA) in adults increases the risk for hypertension, coronary artery disease and stroke, and there is now mounting evidence that SDB also has a significant impact on the cardiovascular system in children with reports of elevated blood pressure, endothelial dysfunction and altered autonomic cardiovascular control.

Oxidative stress seems to play a pivotal role in impairing flow-mediated dilation (FMD) and consequently enhancing cardiovascular risk in SDB patients but the underlying mechanism is still undefined.

Previously, we demonstrated that endothelial dysfunction is directly related to NADPH oxidase activation. Furthermore, recently we assessed the association between OSA, endothelial dysfunction and oxidative stress in adults showing that increased NADPH oxidase-generated oxidative stress and arterial dysfunction are partially reversed by nasal continuous positive airway pressure treatment.

There is evidence in literature that cardiovascular morbidities associated with SDB are potentially reversible in children; AT may have a significant role in reversing the cardiovascular sequelae of SDB (e.g. children with OSA).

Nowadays, there aren't studies that analyzed the role of NADPH oxidase-generated oxidative stress in SDB children.

The purpose of the current research project is to examine the role of NADPH oxidase activity, oxidative stress, inflammation and endothelial function in SDB children, understanding the mechanisms involved in this disease.

Furthermore we will analyse the effect of a AT on inflammation, oxidative stress, NADPH oxidase activity and endothelial function in SDB children.

Conditions

  • Obstructive Sleep Apnea of Child

Interventions

PROCEDURE

adenotonsillectomy

adenotonsillectomy in children with OSAS and adenotonsillar hypertrophy.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Francesco Violi, MD · Sapienza University

  • Marzia Duse, MD · Sapienza University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02247167 on ClinicalTrials.gov