Pilot Study to Assess the Effectiveness of Tonsil and Adenoidectomy (T+A) in Overweight Children and Adolescents
This study is currently recruiting patients
Verified by University of Rochester September 2006
| Sponsored by: |
University of Rochester |
| Information provided by: |
University of Rochester |
| ClinicalTrials.gov Identifier: |
NCT00222963 |
Purpose
Obesity has reached epidemic proportions in the United States with roughly 20% of American children being overweight and has serious consequences such as 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. 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. 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.
| Condition |
Obesity Obstructive Sleep Apnea Syndrome |
Study Type: Observational Study Design: Natural History, Longitudinal, Convenience Sample, Prospective Study
Official Title: Pilot Study to Assess the Effectiveness of Tonsil and Adenoidectomy (T+A) in Overweight Children and Adolescents
Further study details as provided by University of Rochester:
Expected Total Enrollment:
100
Study start: September 2004
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.
Eligibility
Ages Eligible for Study:
8 Years
-
18 Years,
Genders Eligible for Study:
Both
Criteria
Inclusion Criteria:
- Children aged 8-18 who are overweight or at risk for overweight (defined as BMI >85%ile for age and gender referred for evaluation
and treatment of sleep apnea.
Exclusion Criteria:
- Children with underlying craniofacial anomalies, chromosomal abnormalities, neuromuscular disorders and metabolic disorders
except diabetes will be excluded. Children and parents who do not speak or write English will be excluded. Children with
neuropsychiatric disabilities severe enough to preclude sufficient cooperation with overnight polysomnography will also be
excluded.
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00222963
New YorkUniversity of Rochester, Rochester,
New York,
14642,
United States; Recruiting
Margaret-Ann Carno, PhD,RN
585-273-4743
margaret_carno@urmc.rochester.edu
Heidi V. Connolly, MD
585-341-7575
heidi_connolly@urmc.rochester.edu
Heidi V. Connolly, MD, Principal Investigator Margaret-Ann Carno, PhD, RN, Sub-Investigator Stephen R. Cook, MD, Sub-Investigator Joseph A. Modrak, MD, Sub-Investigator Kenneth Whittemore, MD, Sub-Investigator Rachel Kraus, RN,PNP, Sub-Investigator Ethan Ellis, Sub-Investigator
Study chairs or principal investigators
Heidi V. Connolly, MD, Principal Investigator, University of Rochester
Margaret-Ann Carno, PhD,RN, Principal Investigator, University of Rochester
More Information
Study ID Numbers:
10297
Last Updated:
September 6, 2006
Record first received:
September 15, 2005
ClinicalTrials.gov Identifier:
NCT00222963Health Authority: United States: Institutional Review Board ClinicalTrials.gov processed this record on 2006-10-03
|