This trial is active, not recruiting.

Conditions obstructive sleep apnea, snoring
Treatments adenotonsillectomy (at) - removal of adenoids and tonsils, watchful waiting
Sponsor University of Pennsylvania
Collaborator Harvard University
Start date October 2007
End date March 2012
Trial size 460 participants
Trial identifier NCT00560859, 5U01HL083129-05, 804695


The purpose of this research is to determine the effect of adenotonsillectomy surgery (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children. OSAS can cause health problems including poor growth, high blood pressure, diabetes and behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve afterwards. This study will help determine if improvement occurs or if it does not. It will also look at whether certain groups, such as children who are overweight or of different ethnicities, are helped by the surgery.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
(Active Comparator)
Children will be closely monitored and receive adenotonsillectomy (AT) within 4 weeks of the baseline visit.
adenotonsillectomy (at) - removal of adenoids and tonsils EAT
Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
watchful waiting Watchful Waiting with Supportive Care (WWSC)
Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Primary Outcomes

To determine improvements in neurocognitive functioning post surgery, the Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY), will be compared between the two arms.
time frame: The primary endpoint measure will occur at 7 months following the baseline visit.

Secondary Outcomes

The Apnea Hypopnea Index (AHI) score will be compared between the two groups to determine whether an improvement in score is associated with improved OSAS (i.e. reduction in AHI).
time frame: 7 months following the baseline visit.
To determine the effects of AT surgery on subgroups by race and weight.
time frame: 7 months following baseline.

Eligibility Criteria

Male or female participants from 5 years up to 9 years old.

Inclusion Criteria: 1. Ages 5.0 to 9.99 years at time of screening. 2. Diagnosed with Obstructive Sleep Apnea defined as: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 2, confirmed on nocturnal, laboratory-based PSG and Parental report of habitual snoring (on average occurring >3 nights per week). 3. Tonsillar hypertrophy ≥ 1 based on a standardized scale of 0-4: 0 = surgically absent, 1 = taking up < 25% of the airway, 2 = 25 - 50 % of the airway,3 = 50 - 75 % of the airway, 4 = > 75% of the airway 4. Deemed to be a surgical candidate for AT by ENT evaluation. Exclusion Criteria: 1. Recurrent tonsillitis defined as: >3 episodes in each of 3 years, 5 episodes in each of 2 years, or 7 episodes in one year 2. Craniofacial anomalies, including cleft lip and palate or sub-mucosal cleft palate or any anatomic or systemic condition which would interfere with general anesthesia or removal of tonsils and adenoid tissue in the standard fashion 3. Obstructive breathing while awake that merits prompt AT in the opinion of the child's physician 4. Severe OSAS or significant hypoxemia requiring immediate AT as defined by: OAI>20 or AHI>30, desaturation defined as SaO2 <90% for more than 2% sleep time 5. Apnea hypopnea indices in the normal range (OAI < 1 and AHI <2) 6. Evidence of clinically significant cardiac arrhythmia on PSG: Non-sustained ventricular tachycardia Atrial fibrillation, Second degree AV block: Sustained bradycardia < 40 bpm (> 2 minutes, Sustained tachycardia > 140 bpm (> 2 minutes) 7. Extremely overweight defined as: body mass index > 2.99 age group and sex-z-score 8. Severe health problems that could be exacerbated by delayed treatment for OSAS Including: Doctor-diagnosed heart disease or cor pulmonale, history of Stage II Hypertension (HTN) defined as > 99% percentile plus 5 mmHg for either systolic or diastolic, based on the age, gender, and height and/or requiring medication, therapy for failure to thrive or short stature, psychiatric or behavioral disorders requiring or likely to require initiation of new medication, therapy, or other specific treatment. School aged children, parental report of excessive daytime sleepiness defined as unable to maintain wakefulness, at least three times per week, in routine activities in school or home, despite adequate opportunity to sleep. 9. Severe chronic health conditions that might hamper participation including: severe cardiopulmonary disorders, sickle cell anemia, poorly controlled asthma, epilepsy requiring medication, diabetes (type I or type II) requiring medication, conditions likely to preclude accurate polysomnography (e.g. severe uncontrolled pain),mental retardation or enrollment in a formal school Individual Educational Plan (IEP) and assigned to a self-contained classroom for all academic subjects, history of inability to complete cognitive testing and/or score on DAS II of ≤ 55, chronic infection or HIV 10. Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition, or behavior 11. Current use of one or more of the following medications: ADHD,psychotropics, hypnotics,hypoglycemic agents or insulin,antihypertensives,growth hormone, anticonvulsants,anti-coagulants,daily oral corticosteroids, daily medications for pain 12. Previous upper airway surgery on the nose, pharynx or larynx, including tonsillectomy. Ear surgery and/or PE tubes are not exclusion criteria 13. Receives Continuous Positive Airway Pressure (CPAP) treatment 14. A parent or guardian who cannot accompany the child on the night of PSG 15. A family planning to move out of the area within the year 16. Female participants only: Parental report that child has reached menarche

Additional Information

Official title A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome
Principal investigator Ron Chervin, MD, MS
Description Because adenotonsillectomy is the usual treatment for OSAS, all children in the study will get surgery. However, in order to assess the extent to which adenotonsillectomy surgery improves breathing disturbances and sleep quality in children with OSAS, two groups will be studied. One group will get surgery early (one month after enrollment) and the other group will be re-evaluated for surgery within 7 months of enrollment. Children in both groups will be closely monitored through the 7-8 month study period and sleep and health educational materials will be provided to assist in establishing healthy habits.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by University of Pennsylvania.