作者
Susan Redline,Kaitlyn Cook,Ronald D. Chervin,Stacey L. Ishman,Cristina Baldassari,Ron B. Mitchell,Ignacio E. Tapia,Raouf S. Amin,Fauziya Hassan,Sally Ibrahim,Kristie Ross,Lisa Elden,Erin M. Kirkham,David A. Zopf,Jay Shah,Todd Otteson,Kamal Naqvi,Judith Owens,Lisa R. Young,Susan L. Furth,Heidi Connolly,Caron A. C. Clark,Jessie P. Bakker,Susan L. Garetz,Jerilynn Radcliffe,H. Gerry Taylor,Carol L. Rosen,Rui Wang,Michael Rueschman,Meg Tully,Jean L. Arnold,Michelle Nicholson,Emily R Kaplan,Daniel Mobley,Michael G. Morrical,Laurie Karamessinis,Michelle Ward,Mary Anne Cornaglia,Ruth Bradford,Alyssa M. Ciampaglia,Hayley Groubert,Erica Denallo,Rasal Rajashari,Morgan Pyzoha,Heather Rogers,K. Ingrid McKibben,Stephanie Hicks,B Carter,Melodie Boh,K. Swegheimer,Stacey Niehaus,Emily Herresoff,M L Heffner,Judy Fetterolf,Bill Geal,Sarah McCarthy,Braden DeWeese,Lyndsey Johnson,Kristin Brierly,Allison Jordan,Karel Pavelka,James Sands,Ashley Szpara,Francesca Chambers,Laura Vargas,Constance Eshon,Florence George,Mary A. Martin,Vernell Sparks,Victoria A. Young,Laura S. Stone,A. R. sk Boykin,Emily I. Riggan,Thomas Boswick,Michael Bailey,Amanda Stetler,Addy Tham
摘要
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