Childhood Adenotonsillectomy Study for Children With OSAS

NCT00560859 | Completed Results DMC

• 2 other identifiers: 8046955U01HL083129-05
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Snoring

Keywords

Sleep disordered breathing; Sleep apnea; Tonsillectomy; Adenoidectomy; Snoring; Neurobehavioral Manifestations; Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.

  The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.

  The primary endpoint measure will occur at 7 months following the baseline visit.

Secondary Outcomes (2)

• Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months

  7 months following the baseline visit.

• Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale

  7 months following baseline.

Study Arms (2)

Early AT Surgery

ACTIVE COMPARATOR

There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit.

Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils

Watchful Waiting

OTHER

Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.

Other: Watchful Waiting

Interventions

Adenotonsillectomy (AT) - removal of adenoids and tonsils PROCEDURE

Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils

Also known as: EAT

Early AT Surgery

Watchful Waiting OTHER

Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Also known as: Watchful Waiting with Supportive Care (WWSC)

Watchful Waiting

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 5.0 to 9.99 years at time of screening.
• 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).
• 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
• Deemed to be a surgical candidate for AT by Ear, Nose and Throat specialist (ENT) evaluation.

You may not qualify if:

• Recurrent tonsillitis defined as: \>3 episodes in each of 3 years, 5 episodes in each of 2 years, or 7 episodes in one year
• 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
• Obstructive breathing while awake that merits prompt AT in the opinion of the child's physician
• 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
• Apnea hypopnea indices in the normal range (OAI \< 1 and AHI \<2)
• 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)
• Extremely overweight defined as: body mass index \> 2.99 age group and sex-z-score
• 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.
• 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
• Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition, or behavior
• 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
• Receives Continuous Positive Airway Pressure (CPAP) treatment
• A parent or guardian who cannot accompany the child on the night of polysomnogram (PSG)
• A family planning to move out of the area within the year
• Female participants only: Parental report that child has reached menarche

Sponsors & Collaborators

• University of Pennsylvania: lead
• Harvard University: collaborator
• University of Michigan: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (6)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63110, United States

Location

Montefiore Children's Hospital

New York, New York, 10467, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19401, United States

Location

Related Publications (30)

• Tsou PY, Alex RM, Redline S, Sands SA. Pathophysiological Traits in Pediatric Obstructive Sleep Apnea. Associations with Patient Characteristics and Responses to Therapy: A Secondary Analysis of the CHAT Clinical Trial. Ann Am Thorac Soc. 2025 Dec;22(12):1931-1941. doi: 10.1513/AnnalsATS.202412-1302OC.

  PMID: 40720163 DERIVED

• 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.

  PMID: 40676770 DERIVED

• 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.

  PMID: 40587023 DERIVED

• 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.

  PMID: 38382311 DERIVED

• 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.

  PMID: 37590002 DERIVED

• Williamson AA, Fan J, Distel L, Xiao R, Stefanovski D, Tapia IE. Nighttime sleep duration and variability in children with obstructive sleep apnea syndrome: Sociodemographic disparities and neurobehavioral outcomes. Sleep Med. 2023 Feb;102:165-172. doi: 10.1016/j.sleep.2023.01.003. Epub 2023 Jan 10.

  PMID: 36682144 DERIVED

• 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.

  PMID: 36434376 DERIVED

• Yu PK, Radcliffe J, Gerry Taylor H, Amin RS, Baldassari CM, Boswick T, Chervin RD, Elden LM, Furth SL, Garetz SL, George A, Ishman SL, Kirkham EM, Liu C, Mitchell RB, Kamal Naqvi S, Rosen CL, Ross KR, Shah JR, Tapia IE, Young LR, Zopf DA, Wang R, Redline S. Neurobehavioral morbidity of pediatric mild sleep-disordered breathing and obstructive sleep apnea. Sleep. 2022 May 12;45(5):zsac035. doi: 10.1093/sleep/zsac035. Epub 2022 Feb 12.

  PMID: 35554583 DERIVED

• 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.

  PMID: 34499109 DERIVED

• 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.

  PMID: 34498074 DERIVED

• 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.

  PMID: 32880655 DERIVED

• 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.

  PMID: 32777055 DERIVED

• 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.

  PMID: 32222900 DERIVED

• 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.

  PMID: 31533972 DERIVED

• 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.

  PMID: 30798410 DERIVED

• 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.

  PMID: 30212861 DERIVED

• 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.

  PMID: 30165465 DERIVED

• 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.

  PMID: 28199697 DERIVED

• 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.

  PMID: 27811072 DERIVED

• 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.

  PMID: 27768852 DERIVED

• 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.

  PMID: 27568804 DERIVED

• Taylor HG, Bowen SR, Beebe DW, Hodges E, Amin R, Arens R, Chervin RD, Garetz SL, Katz ES, Moore RH, Morales KH, Muzumdar H, Paruthi S, Rosen CL, Sadhwani A, Thomas NH, Ware J, Marcus CL, Ellenberg SS, Redline S, Giordani B. Cognitive Effects of Adenotonsillectomy for Obstructive Sleep Apnea. Pediatrics. 2016 Aug;138(2):e20154458. doi: 10.1542/peds.2015-4458.

  PMID: 27464674 DERIVED

• 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.

  PMID: 26414902 DERIVED

• Chervin RD, Ellenberg SS, Hou X, Marcus CL, Garetz SL, Katz ES, Hodges EK, Mitchell RB, Jones DT, Arens R, Amin R, Redline S, Rosen CL; Childhood Adenotonsillectomy Trial. Prognosis for Spontaneous Resolution of OSA in Children. Chest. 2015 Nov;148(5):1204-1213. doi: 10.1378/chest.14-2873.

  PMID: 25811889 DERIVED

• 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.

  PMID: 25669177 DERIVED

• 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.

  PMID: 25601979 DERIVED

• 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.

  PMID: 25474490 DERIVED

• Katz ES, Moore RH, Rosen CL, Mitchell RB, Amin R, Arens R, Muzumdar H, Chervin RD, Marcus CL, Paruthi S, Willging P, Redline S. Growth after adenotonsillectomy for obstructive sleep apnea: an RCT. Pediatrics. 2014 Aug;134(2):282-9. doi: 10.1542/peds.2014-0591.

  PMID: 25070302 DERIVED

• Weinstock TG, Rosen CL, Marcus CL, Garetz S, Mitchell RB, Amin R, Paruthi S, Katz E, Arens R, Weng J, Ross K, Chervin RD, Ellenberg S, Wang R, Redline S. Predictors of obstructive sleep apnea severity in adenotonsillectomy candidates. Sleep. 2014 Feb 1;37(2):261-9. doi: 10.5665/sleep.3394.

  PMID: 24497655 DERIVED

• Marcus CL, Moore RH, Rosen CL, Giordani B, Garetz SL, Taylor HG, Mitchell RB, Amin R, Katz ES, Arens R, Paruthi S, Muzumdar H, Gozal D, Thomas NH, Ware J, Beebe D, Snyder K, Elden L, Sprecher RC, Willging P, Jones D, Bent JP, Hoban T, Chervin RD, Ellenberg SS, Redline S; Childhood Adenotonsillectomy Trial (CHAT). A randomized trial of adenotonsillectomy for childhood sleep apnea. N Engl J Med. 2013 Jun 20;368(25):2366-76. doi: 10.1056/NEJMoa1215881. Epub 2013 May 21.

  PMID: 23692173 DERIVED

Related Links

• National Center on Sleep Disorder Research

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring; Sleep Apnea Syndromes; Neurobehavioral Manifestations

Interventions

Adenoidectomy; Watchful Waiting; Palliative Care

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Children under 5 years of age, in whom OSAS is common, were not included. Children on medications for ADHD or with prolonged oxygen-hemoglobin desaturation were also excluded, so results cannot be extrapolated to such children.

Results Point of Contact

• Title: Dr. Susan S. Ellenberg
• Organization: University of Pennsylvania

sellenbe@upenn.edu

215-573-3904

Study Officials

• Susan Redline, MD, MPH

  Harvard University

  STUDY CHAIR

• Susan Ellenberg, Ph.D.

  University of Pennsylvania

  STUDY DIRECTOR

• Ron Chervin, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Bruno Giordani, PH.D.

  Univeristy of Michigan

  STUDY DIRECTOR

• Susan Garetz, MD

  University of Michigan

  STUDY DIRECTOR

• Raouf Amin, MD

  Cincinnati Children's Hopsital Medical Center (CCHMC)

  PRINCIPAL INVESTIGATOR

• Carole Marcus, MBB Ch.

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Carol Rosen, MD

  Case University School of Medicine; Rainbow Babies & Children's Hospital

  PRINCIPAL INVESTIGATOR

• Ron Mitchell, MD

  Cardinal Glennon Children's Medical Center, St. Louis MO

  PRINCIPAL INVESTIGATOR

• Raanan Arens, MD

  Montefiore Children's Hospital Albert Einstein Med Ctr, NY NY

  PRINCIPAL INVESTIGATOR

• Hiren Muzumdar, MD

  Montefiore Chilren's Hospital Albert Einstein Med Ctr, NY NY

  PRINCIPAL INVESTIGATOR

• Eliot Katz, MD

  Boston Children's Hospital, Boston MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 15, 2015
• Results First Posted: December 15, 2015

Record last verified: 2015-11

Locations

US (6)