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)?
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.
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.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02315911
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
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 (firstname.lastname@example.org).
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.
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