Endothelial Dysfunction and Oxidative Stress in Children With Sleep Disordered Breathing.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02247167|
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : September 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea of Child||Procedure: adenotonsillectomy||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Endothelial Dysfunction and Oxidative Stress in Children With Sleep Disordered Breathing.|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||July 2014|
Experimental: adenotonsillectomy (AT)
Children with SDB studied before and after before adenotonsillectomy.
adenotonsillectomy in children with OSAS and adenotonsillar hypertrophy.
- Assessment of flow mediated dilation (fmd) [ Time Frame: Baseline, week 4 ]
- Assessment of isoprostanes 8 Iso-pgf2alpha (pg/ml) levels [ Time Frame: Baseline, 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247167
|Sapienza University of Rome, I Clinica Medica, Research Tower|
|Rome, Italy, 00161|
|Principal Investigator:||Francesco Violi, MD||Sapienza University|
|Study Director:||Marzia Duse, MD||Sapienza University|