Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza

Brief 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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Child Procedure: adenotonsillectomy Phase 1 Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: adenotonsillectomy (AT)
Children with SDB studied before and after before adenotonsillectomy.
Procedure: adenotonsillectomy
adenotonsillectomy in children with OSAS and adenotonsillar hypertrophy.




Primary Outcome Measures :
  1. Assessment of flow mediated dilation (fmd) [ Time Frame: Baseline, week 4 ]

Secondary Outcome Measures :
  1. Assessment of isoprostanes 8 Iso-pgf2alpha (pg/ml) levels [ Time Frame: Baseline, 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children with diagnosed sleep breathing disorders

Exclusion Criteria:

  • epilepsy
  • acute or chronic cardiorespiratory or neuromuscular diseases
  • chronic inflammatory diseases
  • liver insufficiency
  • serious renal disorders
  • smoking
  • vitamin assumption

Information from the National Library of Medicine

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


Locations
Layout table for location information
Italy
Sapienza University of Rome, I Clinica Medica, Research Tower
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Layout table for investigator information
Principal Investigator: Francesco Violi, MD Sapienza University
Study Director: Marzia Duse, MD Sapienza University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Francesco Violi, Full professor of Internal Medicine, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02247167     History of Changes
Other Study ID Numbers: Sapienza-sdb
C26A13W4AK ( Other Identifier: Sapienza University )
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: September 23, 2014
Last Verified: September 2014
Keywords provided by Francesco Violi, University of Roma La Sapienza:
obstructive sleep apnoea, oxidative stress, FMD
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases