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

Completed

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT01837459

Run by

Children's Hospital Medical Center, Cincinnati

People needed

231

Starts

2006-11-01

Expected to finish

2015-12-01

Last updated by the study team

2016-04-14

Who can join

Age: 5 and older, up to 13. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal controls will be enrolled from children who have a signed informed consent and who have completed the initial polysomnography; whose history does not reveal any symptoms of obstructive breathing during sleep; and who have a polysomnogram that is considered normal.
• SDB groups will be enrolled from children who have a signed informed consent and who have completed the initial polysomnography with OI>1; whose history includes snoring, hypertrophied tonsils or hypertrophied adenoids. Subjects will be assigned to a study group based on results of the overnight polysomnogram.

You may not qualify if…

• Exclusion criteria:
• Children with positive history of snoring without evidence of AHI> 1 and who do not follow through with tonsillectomy or adenoidectomy surgery.
• Children with chronic pulmonary conditions including asthma (children with mild, intermittent asthma will be included and are defined as use of rescue inhaler < 1/wk unless treatment for exercise induced asthma).
• Children with cardiac disease
• Children with neuromuscular disorders
• Children with developmental delay such as Down syndrome
• Children with chronic renal disease such as chronic pyelonephritis or glomerulonephritis
• Children with endocrinological disorders or who are on chronic steroid therapy including inhaled steroids.
• Children using medications which influence the autonomic nervous system such as adrenergic and cholinergic drugs, alpha and beta blockers, and drugs with parasympatholytic action.
• Children with any acute or chronic inflammatory condition.
• Children with BMI Z score that exceeds 2.9 for age and gender.
• Children who do not complete the first 36 hour AMBP study with a 70% success rate of BP readings.
• Children with a history of chronic or recurrent tonsillitis (by parent or physician report) defined as 6 episodes of tonsillitis / year for a period of one year; 5 episodes of tonsillitis / year for 2 years; 4 episodes of tonsillitis / year for 3 years.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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