Sleep Disordered Breathing in Children: Inflammation and Oxidative Stress

NCT ID: NCT02040701

Last Updated: 2014-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disordered Breathing (SDB) Endothelial Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SDB group

No interventions assigned to this group

Control group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dana Children's hospital, Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Riva Tauman, Dr.

Role: CONTACT

Facility Contacts

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Riva Tauman, Dr.

Role: primary

Other Identifiers

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TASMC-13-RT-06-122-CTIL

Identifier Type: -

Identifier Source: org_study_id

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