@article {Wange033889, author = {Rui Wang and Jessie P. Bakker and Ronald D. Chervin and Susan L. Garetz and Fauziya Hassan and Stacey L. Ishman and Ron B. Mitchell and Michael G. Morrical and Syed K. Naqvi and Jerilynn Radcliffe and Emily I. Riggan and Carol L. Rosen and Kristie Ross and Michael Rueschman and Ignacio E. Tapia and H. Gerry Taylor and David A. Zopf and Susan Redline}, title = {Pediatric Adenotonsillectomy Trial for Snoring (PATS): protocol for a randomised controlled trial to evaluate the effect of adenotonsillectomy in treating mild obstructive sleep-disordered breathing}, volume = {10}, number = {3}, elocation-id = {e033889}, year = {2020}, doi = {10.1136/bmjopen-2019-033889}, publisher = {British Medical Journal Publishing Group}, abstract = {Introduction Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.Methods and analysis The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0{\textendash}12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study{\textquoteright}s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.Ethics and dissemination The study protocol was approved by the institutional review board (IRB) at Children{\textquoteright}s Hospital of Philadelphia (CHOP) on 3 October 2014 (14{\textendash}0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.Trial registration number NCT02562040; Pre-results.}, issn = {2044-6055}, URL = {https://bmjopen.bmj.com/content/10/3/e033889}, eprint = {https://bmjopen.bmj.com/content/10/3/e033889.full.pdf}, journal = {BMJ Open} }