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NCT02040701 Clinical Trial

Sleep Disordered Breathing in Children: Inflammation and Oxidative Stress

Endothelial Dysfunction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02040701
Other study ID # TASMC-13-RT-06-122-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received January 9, 2014
Last updated January 15, 2014
Start date May 2006

Study information
Verified date January 2014
Source Tel-Aviv Sourasky Medical Center
Contact Riva Tauman, Dr.
Email tauman@tlvmc.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 18 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Dana Children's hospital, Tel Aviv Medical Center Tel-Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma inflammatory-markers Sleep disordered breathing (SDB) in children is associated with increased markers of inflammation, atherogenesis and oxidative stress. After the blood analyzed No
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