Childhood Adenotonsillectomy Study for Children With OSAS
NCT ID: NCT00560859
Last Updated: 2015-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
453 participants
INTERVENTIONAL
2007-10-31
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early AT Surgery
There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils
Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils
Watchful Waiting
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Watchful Waiting
Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
Interventions
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Adenotonsillectomy (AT) - removal of adenoids and tonsils
Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils
Watchful Waiting
Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 Ear, Nose and Throat specialist (ENT) evaluation.
Exclusion Criteria
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 oxygen saturation (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 atrioventricular (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 the Differential Ability Scale (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: psychotropics, hypnotics,hypoglycemic agents or insulin,antihypertensives,growth hormone, anticonvulsants,anti-coagulants,daily oral corticosteroids, daily medications for pain
13. Receives Continuous Positive Airway Pressure (CPAP) treatment
14. A parent or guardian who cannot accompany the child on the night of polysomnogram (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
5 Years
9 Years
ALL
No
Sponsors
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Harvard University
OTHER
University of Michigan
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Susan Redline, MD, MPH
Role: STUDY_CHAIR
Harvard University
Susan Ellenberg, Ph.D.
Role: STUDY_DIRECTOR
University of Pennsylvania
Ron Chervin, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Bruno Giordani, PH.D.
Role: STUDY_DIRECTOR
Univeristy of Michigan
Susan Garetz, MD
Role: STUDY_DIRECTOR
University of Michigan
Raouf Amin, MD
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Children's Hopsital Medical Center (CCHMC)
Carole Marcus, MBB Ch.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Carol Rosen, MD
Role: PRINCIPAL_INVESTIGATOR
Case University School of Medicine; Rainbow Babies & Children's Hospital
Ron Mitchell, MD
Role: PRINCIPAL_INVESTIGATOR
Cardinal Glennon Children's Medical Center, St. Louis MO
Raanan Arens, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Children's Hospital Albert Einstein Med Ctr, NY NY
Hiren Muzumdar, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Chilren's Hospital Albert Einstein Med Ctr, NY NY
Eliot Katz, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital, Boston MA
Locations
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Children's Hospital Boston
Boston, Massachusetts, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
Montefiore Children's Hospital
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Ramirez-Contreras C, Elgueta VP, Briones-Suarez L. Childhood OSAS and Obesity: Prospective Associations of Anthropometric Markers With Objective Sleep Outcomes in the CHAT Trial. J Sleep Res. 2025 Jul 17:e70156. doi: 10.1111/jsr.70156. Online ahead of print.
Dai S, Yang M, Au CT, Yuen NTK, Zhang Y, Tang A, Yu MWL, Li AM, Chan KCC. Supine position-related obstructive sleep apnea in children: insights from the Childhood Adenotonsillectomy Trial. Sleep Breath. 2025 Jun 30;29(4):230. doi: 10.1007/s11325-025-03393-1.
Wang C, Sun K, Liu K, Yu Z. Association of allergic rhinitis with persistent obstructive sleep apnea: A secondary analysis of the childhood adenotonsillectomy trial. Sleep Med. 2024 Mar;115:246-250. doi: 10.1016/j.sleep.2024.02.029. Epub 2024 Feb 15.
Wang C, Hu H, Sun K, Ma Y, Lu Y, Liu K, Yu Z. Dysphagia Outcomes Before and After Adenotonsillectomy in Children With Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Oct 1;149(10):878-883. doi: 10.1001/jamaoto.2023.2145.
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Magnusdottir S, Witmans M, Hilmisson H. Sleep quality, sleep apnea, and metabolic health in children treated with adenotonsillectomy. Sleep Breath. 2023 Aug;27(4):1527-1540. doi: 10.1007/s11325-022-02747-3. Epub 2022 Nov 24.
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Snow A, Vazifedan T, Baldassari CM. Evaluation of Nocturnal Enuresis After Adenotonsillectomy in Children With Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Oct 1;147(10):887-892. doi: 10.1001/jamaoto.2021.2303.
Martin-Montero A, Gutierrez-Tobal GC, Kheirandish-Gozal L, Vaquerizo-Villar F, Alvarez D, Del Campo F, Gozal D, Hornero R. Heart rate variability as a potential biomarker of pediatric obstructive sleep apnea resolution. Sleep. 2022 Feb 14;45(2):zsab214. doi: 10.1093/sleep/zsab214.
Isaiah A, Spanier AJ, Grattan LM, Wang Y, Pereira KD. Predictors of Behavioral Changes After Adenotonsillectomy in Pediatric Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):900-908. doi: 10.1001/jamaoto.2020.2432.
Hartmann S, Bruni O, Ferri R, Redline S, Baumert M. Cyclic alternating pattern in children with obstructive sleep apnea and its relationship with adenotonsillectomy, behavior, cognition, and quality of life. Sleep. 2021 Jan 21;44(1):zsaa145. doi: 10.1093/sleep/zsaa145.
Hilmisson H, Berman S, Magnusdottir S. Sleep apnea diagnosis in children using software-generated apnea-hypopnea index (AHI) derived from data recorded with a single photoplethysmogram sensor (PPG) : Results from the Childhood Adenotonsillectomy Study (CHAT) based on cardiopulmonary coupling analysis. Sleep Breath. 2020 Dec;24(4):1739-1749. doi: 10.1007/s11325-020-02049-6. Epub 2020 Mar 28.
Isaiah A, Pereira KD, Das G. Polysomnography and Treatment-Related Outcomes of Childhood Sleep Apnea. Pediatrics. 2019 Oct;144(4):e20191097. doi: 10.1542/peds.2019-1097.
Hilmisson H, Lange N, Magnusdottir S. Objective sleep quality and metabolic risk in healthy weight children results from the randomized Childhood Adenotonsillectomy Trial (CHAT). Sleep Breath. 2019 Dec;23(4):1197-1208. doi: 10.1007/s11325-019-01802-w. Epub 2019 Feb 23.
Hodges E, Marcus CL, Kim JY, Xanthopoulos M, Shults J, Giordani B, Beebe DW, Rosen CL, Chervin RD, Mitchell RB, Katz ES, Gozal D, Redline S, Elden L, Arens R, Moore R, Taylor HG, Radcliffe J, Thomas NH. Depressive symptomatology in school-aged children with obstructive sleep apnea syndrome: incidence, demographic factors, and changes following a randomized controlled trial of adenotonsillectomy. Sleep. 2018 Dec 1;41(12):zsy180. doi: 10.1093/sleep/zsy180.
Liu X, Immanuel S, Kennedy D, Martin J, Pamula Y, Baumert M. Effect of adenotonsillectomy for childhood obstructive sleep apnea on nocturnal heart rate patterns. Sleep. 2018 Nov 1;41(11):zsy171. doi: 10.1093/sleep/zsy171.
Thomas NH, Xanthopoulos MS, Kim JY, Shults J, Escobar E, Giordani B, Hodges E, Chervin RD, Paruthi S, Rosen CL, Taylor GH, Arens R, Katz ES, Beebe DW, Redline S, Radcliffe J, Marcus CL. Effects of Adenotonsillectomy on Parent-Reported Behavior in Children With Obstructive Sleep Apnea. Sleep. 2017 Apr 1;40(4):zsx018. doi: 10.1093/sleep/zsx018.
Liu X, Immanuel S, Pamula Y, Kennedy D, Martin J, Baumert M. Adenotonsillectomy for childhood obstructive sleep apnoea reduces thoraco-abdominal asynchrony but spontaneous apnoea-hypopnoea index normalisation does not. Eur Respir J. 2017 Jan 25;49(1):1601177. doi: 10.1183/13993003.01177-2016. Print 2017 Jan.
Wang R, Dong Y, Weng J, Kontos EZ, Chervin RD, Rosen CL, Marcus CL, Redline S. Associations among Neighborhood, Race, and Sleep Apnea Severity in Children. A Six-City Analysis. Ann Am Thorac Soc. 2017 Jan;14(1):76-84. doi: 10.1513/AnnalsATS.201609-662OC.
Paruthi S, Buchanan P, Weng J, Chervin RD, Mitchell RB, Dore-Stites D, Sadhwani A, Katz ES, Bent J, Rosen CL, Redline S, Marcus CL. Effect of Adenotonsillectomy on Parent-Reported Sleepiness in Children with Obstructive Sleep Apnea. Sleep. 2016 Nov 1;39(11):2005-2012. doi: 10.5665/sleep.6232.
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Paruthi S, Rosen CL, Wang R, Weng J, Marcus CL, Chervin RD, Stanley JJ, Katz ES, Amin R, Redline S. End-Tidal Carbon Dioxide Measurement during Pediatric Polysomnography: Signal Quality, Association with Apnea Severity, and Prediction of Neurobehavioral Outcomes. Sleep. 2015 Nov 1;38(11):1719-26. doi: 10.5665/sleep.5150.
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Quante M, Wang R, Weng J, Rosen CL, Amin R, Garetz SL, Katz E, Paruthi S, Arens R, Muzumdar H, Marcus CL, Ellenberg S, Redline S; Childhood Adenotonsillectomy Trial (CHAT). The Effect of Adenotonsillectomy for Childhood Sleep Apnea on Cardiometabolic Measures. Sleep. 2015 Sep 1;38(9):1395-403. doi: 10.5665/sleep.4976.
Garetz SL, Mitchell RB, Parker PD, Moore RH, Rosen CL, Giordani B, Muzumdar H, Paruthi S, Elden L, Willging P, Beebe DW, Marcus CL, Chervin RD, Redline S. Quality of life and obstructive sleep apnea symptoms after pediatric adenotonsillectomy. Pediatrics. 2015 Feb;135(2):e477-86. doi: 10.1542/peds.2014-0620. Epub 2015 Jan 19.
Mitchell RB, Garetz S, Moore RH, Rosen CL, Marcus CL, Katz ES, Arens R, Chervin RD, Paruthi S, Amin R, Elden L, Ellenberg SS, Redline S. The use of clinical parameters to predict obstructive sleep apnea syndrome severity in children: the Childhood Adenotonsillectomy (CHAT) study randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2015 Feb;141(2):130-6. doi: 10.1001/jamaoto.2014.3049.
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Related Links
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National Center on Sleep Disorder Research
Other Identifiers
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804695
Identifier Type: -
Identifier Source: org_study_id