Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial | Otolaryngology | JN Learning | AMA Ed Hub [Skip to Content]
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Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep ApneaA Randomized Clinical Trial

Educational Objective
To determine whether adenotonsillectomy is more effective than watchful waiting for treating otherwise healthy children with mild to moderate obstructive sleep apnea (OSA).
1 Credit CME
Key Points

Question  Is adenotonsillectomy (ATE) more effective than watchful waiting for treating otherwise healthy children, between 2 and 4 years of age, with mild to moderate obstructive sleep apnea (OSA)?

Findings  In this randomized clinical trial including 60 children with OSA, there were only small differences between outcomes of ATE and watchful waiting, in favor of ATE, regarding changes in mean obstructive apnea–hypopnea index (OAHI), but there were large improvements in quality of life after ATE. Also, subgroup analyses showed that 11 children with moderate OSA who received ATE had a meaningful improvement in OAHI compared with 13 who received watchful waiting.

Meaning  Children with moderate OSA should be considered for early ATE, while children with mild OSA and mild effect on quality of life may benefit from a period of watchful waiting.

Abstract

Importance  Adenotonsillectomy (ATE) is one of the most common surgical procedures to treat children with obstructive sleep apnea (OSA), but to our knowledge there are no randomized clinical trials confirming the benefit of surgery compared with watchful waiting in children between 2 and 4 years of age.

Objective  To determine whether ATE is more effective than watchful waiting for treating otherwise healthy children with mild to moderate OSA.

Design, Setting, and Participants  This randomized clinical trial was conducted from December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden. A total of 60 children, 2 to 4 years of age, with an obstructive apnea–hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n = 29) or watchful waiting (n = 31). A total of 53 participants (88%; ATE, n = 25; watchful waiting, n = 28) completed the study. Data were analyzed from August 2018 to December 2018.

Interventions  Adenotonsillectomy.

Main Outcomes and Measures  The primary outcome was the difference between the groups in mean OAHI score change. Secondary outcomes were other polysomnography parameters, score on the Obstructive Sleep Apnea–18 (OSA–18) questionnaire, and subgroup analyses. Polysomnography and the OSA–18 questionnaire were completed at baseline and after 6 months.

Results  Of the 60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months. Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (−1.0; 95% CI, −2.4 to 0.5), in favor of ATE. However, there were large differences between the groups in favor of ATE regarding the OSA–18 questionnaire (eg, total OSA–18 score: −17; 95% CI, −24 to −10). Also, a subgroup analysis of 24 children with moderate OSA (OAHI ≥5 and <10) showed a meaningful difference in mean OAHI score change between the groups in favor of ATE (−3.1; 95% CI, −5.7 to −0.5). Of 28 children, 10 (36%) in the watchful waiting group received ATE after the follow-up, and 7 of these had moderate OSA at baseline.

Conclusions and Relevance  This randomized clinical trial found only small differences between the groups regarding changes in OAHI, but further studies are needed. However, there were large improvements in quality of life after ATE. These results suggest that otherwise healthy children with mild OSA and mild effect on quality of life may benefit from watchful waiting, while children with moderate OSA should be considered for ATE.

Trial Registration  ClinicalTrials.gov Identifier: NCT02315911

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Article Information

Accepted for Publication: March 29, 2020.

Published Online: May 28, 2020. doi:10.1001/jamaoto.2020.0869

Correction: This article was corrected on October 29, 2020, to fix an error in the Results section that read “greater” rather than “less.”

Corresponding Author: Johan Fehrm, MD, Department of Otorhinolaryngology, Karolinska University Hospital, 141 86 Stockholm, Sweden (johan.fehrm@sll.se).

Author Contributions: Dr Fehrm had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Fehrm, Nerfeldt, Friberg.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Fehrm.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Fehrm, Browaldh, Friberg.

Obtained funding: Fehrm, Friberg.

Administrative, technical, or material support: Fehrm, Nerfeldt, Friberg.

Supervision: Nerfeldt, Browaldh, Friberg.

Conflict of interest Disclosures: Dr Fehrm reported grants from the Samaritan Foundation for Pediatric Research, from the ACTA Oto-Laryngologica Foundation, and from the Stockholm City Council during the conduct of the study. No other disclosures were reported.

Funding/Support: This study was supported by grants from the Stockholm County Council (ALF project), the ACTA Oto-Laryngologica Foundation, and the Samaritan Foundation for Pediatric Research.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 2.

Additional Contributions: We thank our colleagues at the Otorhinolaryngology Department, Karolinska University Hospital, for recruiting and operating on the study patients; Anne-Charlotte Hessén-Söderman, MD, PhD, for operating and performing follow-up on study patients; statistician Johan Bring, PhD, for providing statistical advice; polysomnographic technologist Therese Murphy for interpreting the polysomnography results; and nurse Carina Hedenström and other personnel for assisting in the sleep laboratory. They received no extra compensation beyond normal salary.

References
1.
Bixler  EO , Vgontzas  AN , Lin  H-M ,  et al.  Sleep disordered breathing in children in a general population sample: prevalence and risk factors.   Sleep. 2009;32(6):731-736.PubMedGoogle ScholarCrossref
2.
Li  AM , So  HK , Au  CT ,  et al.  Epidemiology of obstructive sleep apnoea syndrome in Chinese children: a two-phase community study.   Thorax. 2010;65(11):991-997. doi:10.1136/thx.2010.134858PubMedGoogle ScholarCrossref
3.
Kheirandish-Gozal  L , Gozal  D .  Pediatric OSA syndrome morbidity biomarkers: the hunt is finally on!   Chest. 2017;151(2):500-506. doi:10.1016/j.chest.2016.09.026PubMedGoogle ScholarCrossref
4.
Taylor  HG , Bowen  SR , Beebe  DW ,  et al.  Cognitive effects of adenotonsillectomy for obstructive sleep apnea.   Pediatrics. 2016;138(2):e20154458-e20154458. doi:10.1542/peds.2015-4458PubMedGoogle ScholarCrossref
5.
Hunter  SJ , Gozal  D , Smith  DL , Philby  MF , Kaylegian  J , Kheirandish-Gozal  L .  Effect of sleep-disordered breathing severity on cognitive performance measures in a large community cohort of young school-aged children.   Am J Respir Crit Care Med. 2016;194(6):739-747. doi:10.1164/rccm.201510-2099OCPubMedGoogle ScholarCrossref
6.
Li  AM , Au  CT , Sung  RYT ,  et al.  Ambulatory blood pressure in children with obstructive sleep apnoea: a community based study.   Thorax. 2008;63(9):803-809. doi:10.1136/thx.2007.091132PubMedGoogle ScholarCrossref
7.
Marcus  CL , Brooks  LJ , Draper  KA ,  et al; American Academy of Pediatrics.  Diagnosis and management of childhood obstructive sleep apnea syndrome.   Pediatrics. 2012;130(3):576-584. doi:10.1542/peds.2012-1671PubMedGoogle ScholarCrossref
8.
Friedman  M , Wilson  M , Lin  HC , Chang  HW .  Updated systematic review of tonsillectomy and adenoidectomy for treatment of pediatric obstructive sleep apnea/hypopnea syndrome.   Otolaryngol Head Neck Surg. 2009;140(6):800-808. doi:10.1016/j.otohns.2009.01.043PubMedGoogle ScholarCrossref
9.
Mitchell  RB , Archer  SM , Ishman  SL ,  et al.  Clinical practice guideline: tonsillectomy in children (update)—executive summary.   Otolaryngol Head Neck Surg. 2019;160(2):187-205. doi:10.1177/0194599818807917PubMedGoogle ScholarCrossref
10.
Venekamp  RP , Hearne  BJ , Chandrasekharan  D , Blackshaw  H , Lim  J , Schilder  AG .  Tonsillectomy or adenotonsillectomy versus non-surgical management for obstructive sleep-disordered breathing in children.   Cochrane Database Syst Rev. 2015;14(10):CD011165. doi:10.1002/14651858.CD011165PubMedGoogle Scholar
11.
Chinnadurai  S , Jordan  AK , Sathe  NA , Fonnesbeck  C , McPheeters  ML , Francis  DO .  Tonsillectomy for obstructive sleep-disordered breathing: a meta-analysis.   Pediatrics. 2017;139(2):e20163491. doi:10.1542/peds.2016-3491PubMedGoogle Scholar
12.
Boss  EF , Marsteller  JA , Simon  AE .  Outpatient tonsillectomy in children: demographic and geographic variation in the United States, 2006.   J Pediatr. 2012;160(5):814-819. doi:10.1016/j.jpeds.2011.11.041PubMedGoogle ScholarCrossref
13.
Kaditis  A , Kheirandish-Gozal  L , Gozal  D .  Algorithm for the diagnosis and treatment of pediatric OSA: a proposal of two pediatric sleep centers.   Sleep Med. 2012;13(3):217-227. doi:10.1016/j.sleep.2011.09.009PubMedGoogle ScholarCrossref
14.
Kaditis  AG , Alonso Alvarez  ML , Boudewyns  A ,  et al.  Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management.   Eur Respir J. 2016;47(1):69-94. doi:10.1183/13993003.00385-2015PubMedGoogle ScholarCrossref
15.
Chervin  RD , Ellenberg  SS , Hou  X ,  et al; Childhood Adenotonsillectomy Trial.  Prognosis for spontaneous resolution of OSA in children.   Chest. 2015;148(5):1204-1213. doi:10.1378/chest.14-2873PubMedGoogle ScholarCrossref
16.
Marcus  CL , Moore  RH , Rosen  CL ,  et al; Childhood Adenotonsillectomy Trial (CHAT).  A randomized trial of adenotonsillectomy for childhood sleep apnea.   N Engl J Med. 2013;368(25):2366-2376. doi:10.1056/NEJMoa1215881PubMedGoogle ScholarCrossref
17.
Garetz  SL , Mitchell  RB , Parker  PD ,  et al.  Quality of life and obstructive sleep apnea symptoms after pediatric adenotonsillectomy.   Pediatrics. 2015;135(2):e477-e486. doi:10.1542/peds.2014-0620PubMedGoogle ScholarCrossref
18.
Stewart  MG , Glaze  DG , Friedman  EM , Smith  EO , Bautista  M .  Quality of life and sleep study findings after adenotonsillectomy in children with obstructive sleep apnea.   Arch Otolaryngol Head Neck Surg. 2005;131(4):308-314. doi:10.1001/archotol.131.4.308PubMedGoogle ScholarCrossref
19.
Mitchell  RB , Garetz  S , Moore  RH ,  et al.  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;141(2):130-136. doi:10.1001/jamaoto.2014.3049PubMedGoogle ScholarCrossref
20.
Borgström  A , Nerfeldt  P , Friberg  D .  Questionnaire OSA-18 has poor validity compared to polysomnography in pediatric obstructive sleep apnea.   Int J Pediatr Otorhinolaryngol. 2013;77(11):1864-1868. doi:10.1016/j.ijporl.2013.08.030PubMedGoogle ScholarCrossref
21.
De Luca Canto  G , Pachêco-Pereira  C , Aydinoz  S ,  et al.  Adenotonsillectomy complications: a meta-analysis.   Pediatrics. 2015;136(4):702-718. doi:10.1542/peds.2015-1283PubMedGoogle ScholarCrossref
22.
Amoils  M , Chang  KW , Saynina  O , Wise  PH , Honkanen  A .  Postoperative complications in pediatric tonsillectomy and adenoidectomy in ambulatory vs inpatient settings.   JAMA Otolaryngol Head Neck Surg. 2016;142(4):344-350. doi:10.1001/jamaoto.2015.3634PubMedGoogle ScholarCrossref
23.
Brodsky  L .  Modern assessment of tonsils and adenoids.   Pediatr Clin North Am. 1989;36(6):1551-1569. doi:10.1016/S0031-3955(16)36806-7PubMedGoogle ScholarCrossref
24.
Berry  RB , Budhiraja  R , Gottlieb  DJ ,  et al; American Academy of Sleep Medicine; Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine.  Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events.   J Clin Sleep Med. 2012;8(5):597-619. doi:10.5664/jcsm.2172PubMedGoogle ScholarCrossref
25.
Franco  RA  Jr , Rosenfeld  RM , Rao  M .  First place–resident clinical science award 1999. Quality of life for children with obstructive sleep apnea.   Otolaryngol Head Neck Surg. 2000;123(1, pt 1):9-16. doi:10.1067/mhn.2000.105254PubMedGoogle ScholarCrossref
26.
Lee  CH , Hsu  WC , Chang  WH , Lin  MT , Kang  KT .  Polysomnographic findings after adenotonsillectomy for obstructive sleep apnoea in obese and non-obese children: a systematic review and meta-analysis.   Clin Otolaryngol. 2016;41(5):498-510. doi:10.1111/coa.12549PubMedGoogle ScholarCrossref
27.
Li  AM , Au  CT , Ng  SK ,  et al.  Natural history and predictors for progression of mild childhood obstructive sleep apnoea.   Thorax. 2010;65(1):27-31. doi:10.1136/thx.2009.120220PubMedGoogle ScholarCrossref
28.
Mitchell  RB , Kelly  J , Call  E , Yao  N .  Quality of life after adenotonsillectomy for obstructive sleep apnea in children.   Arch Otolaryngol Head Neck Surg. 2004;130(2):190-194. doi:10.1001/archotol.130.2.190PubMedGoogle ScholarCrossref
29.
Borgström  A , Nerfeldt  P , Friberg  D .  Adenotonsillotomy versus adenotonsillectomy in pediatric obstructive sleep apnea: an RCT.   Pediatrics. 2017;139(4):e20163314. doi:10.1542/peds.2016-3314PubMedGoogle Scholar
30.
Fehrm  J , Nerfeldt  P , Sundman  J , Friberg  D .  Adenopharyngoplasty vs adenotonsillectomy in children with severe obstructive sleep apnea a randomized clinical trial.   JAMA Otolaryngol Head Neck Surg. 2018;144(7):580-586. doi:10.1001/jamaoto.2018.0487PubMedGoogle ScholarCrossref
31.
Volsky  PG , Woughter  MA , Beydoun  HA , Derkay  CS , Baldassari  CM .  Adenotonsillectomy vs observation for management of mild obstructive sleep apnea in children.   Otolaryngol Head Neck Surg. 2014;150(1):126-132. doi:10.1177/0194599813509780PubMedGoogle ScholarCrossref
32.
Gudnadottir  G , Ellegård  E , Hellgren  J .  Intranasal budesonide and quality of life in pediatric sleep-disordered breathing: a randomized controlled trial.   Otolaryngol Head Neck Surg. 2018;158(4):752-759. doi:10.1177/0194599817742597PubMedGoogle ScholarCrossref
33.
Kuhle  S , Hoffmann  DU , Mitra  S , Urschitz  MS .  Anti-inflammatory medications for obstructive sleep apnoea in children.   Cochrane Database Syst Rev. 2020;1(1):CD007074. doi:10.1002/14651858.CD007074.pub3PubMedGoogle Scholar
34.
Bluher  AE , Brawley  CC , Cunningham  TD , Baldassari  CM .  Impact of montelukast and fluticasone on quality of life in mild pediatric sleep apnea.   Int J Pediatr Otorhinolaryngol. 2019;125(April):66-70. doi:10.1016/j.ijporl.2019.06.027PubMedGoogle ScholarCrossref
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