Sleep Disordered Breathing in Children: Inflammation and Oxidative Stress

January 15, 2014 updated by: Tel-Aviv Sourasky Medical Center

The purpose of the study is to measure markers of inflammatory and oxidative stress known to be associated with cardiovascular morbidity in snoring children.

In addition, to measure markers of local inflammation and to evaluate the response to treatment.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Recruiting
        • Dana Children's hospital, Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children ages 6 months-18 years who will undergo overnight sleep study at the Dana Children's hospital, Tel Aviv Medical Center because of snoring and suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy

Description

Inclusion Criteria:

  • children ages 6 months-18 years
  • suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy

Exclusion Criteria:

  • craniofacial abnormalities
  • neurological disorders
  • genetic disorders
  • infectious disease
  • chronic inflammatory disease
  • any underlying chronic medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
SDB group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma inflammatory-markers
Time Frame: After the blood analyzed
Sleep disordered breathing (SDB) in children is associated with increased markers of inflammation, atherogenesis and oxidative stress.
After the blood analyzed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-13-RT-06-122-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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