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Randomized Controlled Trial
. 2023 Dec 5;330(21):2084-2095.
doi: 10.1001/jama.2023.22114.

Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children: A Randomized Clinical Trial

Susan Redline  1 , Kaitlyn Cook  2   3 , Ronald D Chervin  4 , Stacey Ishman  5 , Cristina M Baldassari  6 , Ron B Mitchell  7 , Ignacio E Tapia  8 , Raouf Amin  9 , Fauziya Hassan  10 , Sally Ibrahim  11 , Kristie Ross  11 , Lisa M Elden  12 , Erin M Kirkham  13 , David Zopf  13 , Jay Shah  14   15 , Todd Otteson  14   15 , Kamal Naqvi  16 , Judith Owens  17 , Lisa Young  8 , Susan Furth  8 , Heidi Connolly  18 , Caron A C Clark  19 , Jessie P Bakker  1 , Susan Garetz  20 , Jerilynn Radcliffe  8 , H Gerry Taylor  21 , Carol L Rosen  22 , Rui Wang  1   3   23 ; Pediatric Adenotonsillectomy Trial for Snoring (PATS) Study Team
Collaborators, Affiliations
Randomized Controlled Trial

Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children: A Randomized Clinical Trial

Susan Redline et al. JAMA. .

Abstract

Importance: The utility of adenotonsillectomy in children who have habitual snoring without frequent obstructive breathing events (mild sleep-disordered breathing [SDB]) is unknown.

Objectives: To evaluate early adenotonsillectomy compared with watchful waiting and supportive care (watchful waiting) on neurodevelopmental, behavioral, health, and polysomnographic outcomes in children with mild SDB.

Design, setting, and participants: Randomized clinical trial enrolling 459 children aged 3 to 12.9 years with snoring and an obstructive apnea-hypopnea index (AHI) less than 3 enrolled at 7 US academic sleep centers from June 29, 2016, to February 1, 2021, and followed up for 12 months.

Intervention: Participants were randomized 1:1 to either early adenotonsillectomy (n = 231) or watchful waiting (n = 228).

Main outcomes and measures: The 2 primary outcomes were changes from baseline to 12 months for caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T score, a measure of executive function; and a computerized test of attention, the Go/No-go (GNG) test d-prime signal detection score, reflecting the probability of response to target vs nontarget stimuli. Twenty-two secondary outcomes included 12-month changes in neurodevelopmental, behavioral, quality of life, sleep, and health outcomes.

Results: Of the 458 participants in the analyzed sample (231 adenotonsillectomy and 237 watchful waiting; mean age, 6.1 years; 230 female [50%]; 123 Black/African American [26.9%]; 75 Hispanic [16.3%]; median AHI, 0.5 [IQR, 0.2-1.1]), 394 children (86%) completed 12-month follow-up visits. There were no statistically significant differences in change from baseline between the 2 groups in executive function (BRIEF GEC T-scores: -3.1 for adenotonsillectomy vs -1.9 for watchful waiting; difference, -0.96 [95% CI, -2.66 to 0.74]) or attention (GNG d-prime scores: 0.2 for adenotonsillectomy vs 0.1 for watchful waiting; difference, 0.05 [95% CI, -0.18 to 0.27]) at 12 months. Behavioral problems, sleepiness, symptoms, and quality of life each improved more with adenotonsillectomy than with watchful waiting. Adenotonsillectomy was associated with a greater 12-month decline in systolic and diastolic blood pressure percentile levels (difference in changes, -9.02 [97% CI, -15.49 to -2.54] and -6.52 [97% CI, -11.59 to -1.45], respectively) and less progression of the AHI to greater than 3 events/h (1.3% of children in the adenotonsillectomy group compared with 13.2% in the watchful waiting group; difference, -11.2% [97% CI, -17.5% to -4.9%]). Six children (2.7%) experienced a serious adverse event associated with adenotonsillectomy.

Conclusions: In children with mild SDB, adenotonsillectomy, compared with watchful waiting, did not significantly improve executive function or attention at 12 months. However, children with adenotonsillectomy had improved secondary outcomes, including behavior, symptoms, and quality of life and decreased blood pressure, at 12-month follow-up.

Trial registration: ClinicalTrials.gov Identifier: NCT02562040.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Redline reported receiving personal fees from Jazz Pharma, Eli Lilly, and ApniMed and receiving grants to institution from the National Institutes of Health (NIH). Dr Chervin reported serving as a consultant for Eli Lilly through a contract between that company and University of Michigan Health; holding a patent for a copyrighted questionnaire about pediatric sleep-disordered breathing, with royalties paid (may receive royalties in future, depending on contract that University of Michigan Health may negotiate with a company); serving on the board of directors (unpaid) and as treasurer for the International Pediatric Sleep Association; and that he was a member of the American Academy of Sleep Medicine board of directors from July 2010 to June 2018 (the views expressed are his own and do not represent the view of the American Academy of Sleep Medicine). Dr Hassan reported serving as a consultant for Eli Lilly. Dr Ibrahim reported receiving research-related funding from Jazz Pharmaceuticals, Avadel Pharmaceuticals, and Harmony Biosciences. Dr Ross reported receiving grants to institution from AstraZeneca and from GlaxoSmithKline to conduct asthma clinical trials and receiving fees from AstraZeneca for advisory board participation related to asthma therapeutics. Dr Kirkham reported receiving grant K23 HL153897-01A1 from the NIH/National Heart, Lung, and Blood Institute (NHLBI) and that she is an author for UpToDate on Adenotonsillectomy for Obstructive Sleep Apnea in Children. Dr Shah reported receiving personal fees from AMBU. Dr Otteson reported receiving grants from NIH/NHLBI. Dr Young reported receiving grants from NIH/NHLBI; Dr Young reported receiving authorship payment from UpToDate Wolters Kluwer, payment from Boehringer Inghelheim for pediatric interstitial lung disease advisory board member roles, advisory fees from Genzyme Sanofi, consulting fees from Roche, and grants from the University of Pennsylvania. Dr Bakker reported receiving salary and shares from Philips, salary and restricted stock units from Signifier Medical Technologies, and personal fees from Koneksa Health, Apnimed, and Digital Medicine Society, a 501(c)(3) non-profit organization. Dr Taylor reported receiving grants from the Abigail Wexner Research Institute at Nationwide Children's Hospital. Dr Rosen reported serving as a board of directors member of the American Academy of Sleep Medicine from 2017 to 2023 (the views expressed are her own and do not represent the view of the American Academy of Sleep Medicine). Dr Wang reported grants to institution from NIH/NHLBI. No other disclosures were reported.

Figures

Figure.
Figure.. Flow of Patients Through the Pediatric Adenotonsillectomy Trial for Snoring
ENT indicates ear, nose, and throat. aReasons for exclusion included apnea-hypopnea index level out of range; severe, chronic health problems; use of study-restricted medications; no report of habitual snoring; tonsillar size less than 2 on Brodsky scale; and lack of clinical equipoise. bRandomization was stratified by age (≤5 vs >5 years), race (Black/African American vs other race or ethnicity), and body mass index (≤85 vs >85th percentile) within each study site. cOne child randomized to watchful waiting was excluded due to site withdrawal but remained in the study and completed 12-month follow-up. dVisit defined as completing either of the primary outcomes (BRIEF [Behavior Rating Inventory of Executive Function] or GNG [Go/No-go]). eAnalyses reported are based on intention-to-treat; participants who crossed over were analyzed based on their randomized treatment assignments. fThe primary analysis used a mixed-effects modeling approach that included observations from study participants at all included sites who had at least 1 measurement.
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