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A Research Study for Children About Heart Changes and Obstructive Sleep Apnea (OSA)

NCT01837459 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 231

Last updated 2016-04-14

No results posted yet for this study

Summary

In this research study the investigators want to learn more about the risk of developing blood vessel and heart disease from night-time sleep apnea. Sleep apnea is a condition that results from blocking of the throat during sleep. This study examines changes in blood pressure, blood vessel stiffness, heart size and levels of specific substances in the blood which may cause heart disease.

This study is for children ages 5 to 13 years. The study involves 3 visits over 18 months. The first and last visits include an overnight sleep study (polysomnography or PSG). All the visits will include:

* body measurements to measure growth and how weight is distributed,
* resting blood pressure measurements,
* heart measurements (electrocardiogram and ultrasounds of the heart and blood vessels),
* 36 hour home ambulatory blood pressure measurements,
* blood tests to look at things like fats, cholesterol, inflammatory factors,
* questionnaires

Optional parts of the study include DNA and for children 8 years and older, testing and questionnaires to learn more about how sleep relates to learning, memory and behavior issues.

Conditions

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Raouf Amin, MD · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
5 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01837459 on ClinicalTrials.gov