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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01HL083129-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Harvard University | OTHER |
| University of Michigan | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early AT Surgery | Active Comparator | There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit. |
|
| Watchful Waiting | Other | Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months | The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States | ||
| Cardinal Glennon Children's Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40720163 | Derived | 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. | |
| 40676770 | 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. 2026 Apr;35(2):e70156. doi: 10.1111/jsr.70156. Epub 2025 Jul 17. |
| Label | URL |
|---|---|
| National Center on Sleep Disorder Research | View source |
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Children were recruited at 7 academic sleep centers. Early in the trial the investigator at one center relocated and that center was withdrawn.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early AT Surgery | Adenotonsillectomy (AT) - removal of tonsils and adenoids - 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. |
| FG001 | Watchful Waiting | Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
These numbers represent all children randomized .
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Early AT Surgery | Adenotonsillectomy (AT) - removal of tonsils and adenoids - 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. |
| BG001 | Watchful Waiting |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | The primary endpoint measure will occur at 7 months following the baseline visit. |
|
Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early AT Surgery | Adenotonsillectomy (AT) - removal of tonsils and adenoids - 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan S. Ellenberg | University of Pennsylvania | 215-573-3904 | sellenbe@upenn.edu |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| D012891 | Sleep Apnea Syndromes |
| D019954 | Neurobehavioral Manifestations |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
| ID | Term |
|---|---|
| D000233 | Adenoidectomy |
| D057832 | Watchful Waiting |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
Not provided
Not provided
Not provided
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|
| Watchful Waiting | Other | Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period. |
|
|
| 7 months following the baseline visit. |
| Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale | Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity. | 7 months following baseline. |
| 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 |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Montefiore Children's Hospital | New York | New York | 10467 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies & Children's Hospital | Cleveland | Ohio | 44106 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19401 | United States |
| 40587023 | 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. |
| 38382311 | 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. |
| 37590002 | 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. |
| 36682144 | 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. |
| 36434376 | 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. |
| 35554583 | 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. |
| 34499109 | 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. |
| 34498074 | 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. |
| 32880655 | 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. |
| 32777055 | 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. |
| 32222900 | 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. |
| 31533972 | 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. |
| 30798410 | 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. |
| 30212861 | 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. |
| 30165465 | 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. |
| 28199697 | 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. |
| 27811072 | 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. |
| 27768852 | 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. |
| 27568804 | 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. |
| 27464674 | 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. |
| 26414902 | 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. |
| 25811889 | 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. |
| 25669177 | 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. |
| 25601979 | 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. |
| 25474490 | 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. |
| 25070302 | 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. |
| 24497655 | 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. |
| 23692173 | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Watchful Waiting | Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period. Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period. |
|
|
|
| Secondary | Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months | The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour. | Posted | Median | Inter-Quartile Range | Events per hour | 7 months following the baseline visit. |
|
|
|
| Secondary | Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale | Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity. | There was missing data for some children in the Watchful Waiting group since the Pediatric Sleep Questionnaire was not completed. Hence these numbers are not consistent with the rows in the participant flow module | Posted | Mean | Standard Deviation | units on a scale | 7 months following baseline. |
|
|
|
| 7 |
| 226 |
| 166 |
| 226 |
| EG001 | 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. | 9 | 227 | 227 | 227 |
| Application site pain | General disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Pleural Effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Adenoviral upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| Allergic cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Allergy to sting | Immune system disorders | Non-systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Application site bleeding | General disorders | Non-systematic Assessment |
|
| Application site rash | General disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Attention Deficit/Hyperactivitiy disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | Non-systematic Assessment |
|
| Blood Glucose | Investigations | Non-systematic Assessment |
|
| Body Tinea | Infections and infestations | Non-systematic Assessment |
|
| Breath Odor | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Choking sensation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Conjuctivits | Eye disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Croup Infectious | Infections and infestations | Non-systematic Assessment |
|
| Croup Non infectious | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Diabetes Mellitus non-insulin dependent | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ear Infection | Infections and infestations | Non-systematic Assessment |
|
| Ear Infection Baceterial | Infections and infestations | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Ear Piercing | Social circumstances | Non-systematic Assessment |
|
| Ear Tube removal | Surgical and medical procedures | Non-systematic Assessment |
|
| electroencephalogram abnormal | Investigations | Non-systematic Assessment |
|
| Emergency care examination normal | Investigations | Non-systematic Assessment |
|
| Enuresis | Renal and urinary disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| External ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Eye Allergy | Eye disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | Non-systematic Assessment |
|
| fever (in the absence of neutropenia, where neutropenia is defined as anc <1.0 x 10e9/l) | General disorders | Non-systematic Assessment |
|
| Finger nail removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis adenovirus | Infections and infestations | Non-systematic Assessment |
|
| gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
|
| gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| genital rash | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Growing pains | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hand fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | Non-systematic Assessment |
|
| head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| Heart rate irregular | Investigations | Non-systematic Assessment |
|
| hordeolum | Infections and infestations | Non-systematic Assessment |
|
| hypersomnia | Nervous system disorders | Non-systematic Assessment |
|
| incision site pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| infected insect bite | Infections and infestations | Non-systematic Assessment |
|
| infection with unknown anc - bladder (urinary) | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| influenza | Infections and infestations | Non-systematic Assessment |
|
| influenza like illness | General disorders | Non-systematic Assessment |
|
| laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lice infestation | Infections and infestations | Non-systematic Assessment |
|
| loss of consciousness | Nervous system disorders | Non-systematic Assessment |
|
| multiple allergies | Immune system disorders | Non-systematic Assessment |
|
| muscle injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nail Tinea | Infections and infestations | Non-systematic Assessment |
|
| nasal cavity/paranasal sinus reactions | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | Non-systematic Assessment |
|
| Otitis media bacterial | Infections and infestations | Non-systematic Assessment |
|
| pain management | Surgical and medical procedures | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| pharyngitis streptococcal | Infections and infestations | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | Non-systematic Assessment |
|
| pneumonia mycoplasmal | Infections and infestations | Non-systematic Assessment |
|
| post procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| postnasal drip | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| postoperative fever | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| precocious puberty | Endocrine disorders | Non-systematic Assessment |
|
| productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pulmonary congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pyrexia | General disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| relapsing fever | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis seasonal | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | Non-systematic Assessment |
|
| road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Scarlet Fever | Infections and infestations | Non-systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis bacterial | Infections and infestations | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sleep Apnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | Non-systematic Assessment |
|
| Sweating fever | Infections and infestations | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | Non-systematic Assessment |
|
| Tongue Tie operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Tonsillitis streptococcal | Infections and infestations | Non-systematic Assessment |
|
| Tooth Infection | Infections and infestations | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tympanometry | Investigations | Non-systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | Non-systematic Assessment |
|
| Varicella | Infections and infestations | Non-systematic Assessment |
|
| vasomotor rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | Non-systematic Assessment |
|
| Viral Rash | Infections and infestations | Non-systematic Assessment |
|
| Viral Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Viral Upper Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |