Pilot Study to Assess the Effectiveness of Tonsil and Adenoidectomy (T+A) in Overweight Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT00222963|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 13, 2009
|Condition or disease|
|Obesity Obstructive Sleep Apnea Syndrome|
Obesity has reached epidemic proportions in the United States with roughly 20% of American children being overweight . Obesity has serious health consequences increasing the risk of hypertension , type II diabetes and obstructive sleep apnea . Additionally, obesity is known to result in the earlier onset of puberty . Thus, it can be expected that obese children take-on adult characteristics at an earlier chronologic age than their non-obese counterparts.
Similarly, sleep apnea is a common problem with wide reaching consequences including increased risk for hypertension , insulin resistance and neurocognitive dysfunction leading to poor academic performance . Furthermore, sleep fragmentation produced by repetitive episodes of nocturnal apnea may lead to daytime somnolence and increased food intake as a behavioral attempt to overcome sleepiness and thereby further contribute to obesity .
Current guidelines recommend adenotonsillectomy (T+A) as primary and effective therapy for sleep apnea resulting in polysomnographic resolution in 75-100% of patients. Small studies have shown that T+A relieves symptoms in obese children but surgical intervention has been less efficacious in adults . Although nocturnal polysomnogrpahy (NPSG) is considered the gold standard by which to diagnose obstructive sleep apnea (OSAS), published studies assessing the efficacy of treatment in obese children using polysomngraphy to objectively quantify the degree of sleep apnea before and after T+A do not exist.
Surgical intervention may not be indicated in children without adenotonsillar hypertrophy. Similarly, children who are at high risk for surgical or anesthetic related complications may be deemed poor surgical candidates. For these children as well as those who fail T+A, non-invasive, continuous positive airway pressure (CPAP) applied via a nasal mask is effective in treating sleep disordered breathing. However, CPAP is effective only when in use and multiple studies demonstrate low rates of long-term compliance in adults . No studies assessing children's adherence with CPAP exist. Certainly, it is expected that compliance in the adolescent population would be similar, if not worse than adults. Thus, CPAP is not recommended as first-line therapy when surgical intervention is viable.
We hypothesize that T+A may be less efficacious in obese adolescents because of earlier onset of puberty imparting more adult characteristics. We further hypothesize that the efficacy of T+A will correlate more closely with Tanner staging than with chronologic age because of the earlier onset of sexual maturation associated with obesity. Thus, we propose to study the efficacy of T+A in the treatment of sleep apnea in obese adolescents using polysomnography to quantify the severity of OSAS before and after T+A. It is anticipated that results from this preliminary study will be used to form the basis for studies comparing efficacy of adenotonsillectomy against the use of CPAP in this population.
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Pilot Study to Assess the Effectiveness of Tonsil and Adenoidectomy (T+A) in Overweight Children and Adolescents|
|Study Start Date :||September 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222963
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Heidi V. Connolly, MD||University of Rochester|
|Principal Investigator:||Margaret-Ann Carno, PhD,RN||University of Rochester|