Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT01837459
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
13 Years
Study:
NCT01837459
Study Brief:
Protocol Section:
NCT01837459