Status:
COMPLETED
A Research Study for Children About Heart Changes and Obstructive Sleep Apnea (OSA)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
5-13 years
Brief 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 blocki...
Detailed Description
This study is designed primarily to investigate the changes in blood vessels compliance and stiffness in children ages 5 to 13 years with the syndrome of obstructive breathing during sleep. It is desi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT01837459
Start Date
November 1 2006
End Date
December 1 2015
Last Update
April 14 2016
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229