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Original Investigation
May 28, 2020

Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden
  • 2Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden
  • 3Division of Otorhinolaryngology, Department of Surgical Science, Uppsala University, Uppsala, Sweden
JAMA Otolaryngol Head Neck Surg. Published online May 28, 2020. doi:10.1001/jamaoto.2020.0869
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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