NCT02040701

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

8 years

First QC Date

January 9, 2014

Last Update Submit

January 15, 2014

Conditions

Sleep Disordered Breathing (SDB)Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Plasma inflammatory-markers

    Sleep disordered breathing (SDB) in children is associated with increased markers of inflammation, atherogenesis and oxidative stress.

    After the blood analyzed

Study Arms (2)

SDB group

Control group

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Children's hospital, Tel Aviv Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Riva Tauman, Dr.

CONTACT

tauman@tlvmc.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 20, 2014

Study Start

May 1, 2006

Primary Completion

May 1, 2014

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

IL(1)