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Randomized Controlled Trial Comparative Study
Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children: A Randomized Clinical Trial.
- Susan Redline, Kaitlyn Cook, Ronald D Chervin, Stacey Ishman, Cristina M Baldassari, Ron B Mitchell, Ignacio E Tapia, Raouf Amin, Fauziya Hassan, Sally Ibrahim, Kristie Ross, Lisa M Elden, Erin M Kirkham, David Zopf, Jay Shah, Todd Otteson, Kamal Naqvi, Judith Owens, Lisa Young, Susan Furth, Heidi Connolly, Caron A C Clark, Jessie P Bakker, Susan Garetz, Jerilynn Radcliffe, H Gerry Taylor, Carol L Rosen, Rui Wang, and Pediatric Adenotonsillectomy Trial for Snoring (PATS) Study Team.
- Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
- JAMA. 2023 Dec 5; 330 (21): 208420952084-2095.
ImportanceThe utility of adenotonsillectomy in children who have habitual snoring without frequent obstructive breathing events (mild sleep-disordered breathing [SDB]) is unknown.ObjectivesTo 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 ParticipantsRandomized 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.InterventionParticipants were randomized 1:1 to either early adenotonsillectomy (n = 231) or watchful waiting (n = 228).Main Outcomes And MeasuresThe 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.ResultsOf 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.ConclusionsIn 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 RegistrationClinicalTrials.gov Identifier: NCT02562040.
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