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

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 3.0-12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study'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's Hospital of Philadelphia (CHOP) on 3 October 2014 (14-0 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.

Keywords: asthma; clinical trial; healthcare use; peadiatrics; sleep apnoea; sleep-disordered breathing; snoring.

Conflict of interest statement

Competing interests: JPB is a full-time employee of Philips, a company that focuses on sleep and respiratory care. JPB also has a part-time appointment at Brigham and Women’s Hospital. JPB's interests have been reviewed and are managed by BWH and Partners HealthCare in accordance with their conflict of interest policies. RDC reports service on the boards of the American Academy of Sleep Medicine, Associated Professional Sleep Societies, American Board of Sleep Medicine, American Academy of Sleep Medicine Foundation, International Paediatric Sleep Association and the not-for-profit Sweet Dreamzzz. He serves as an author and editor for UpToDate. FH has received research funding from Jazz pharmaceuticals and is a consultant for Biogen (Spinraza); none is relevant to this manuscript. CLR is a member of the American Academy of Medicine and the American Academic of Sleep Medicine Foundation Board of Directors. She has received institutional research funding from Jazz Pharmaceuticals and from Flamel (Avadel) Pharmaceuticals unrelated to the submitted work. KR reports non-financial support from Boehringer Ingelheim, grants and non-financial support from TEVA, non-financial support from GSK, non-financial support from Merck, grants from Flamel, grants from Jazz and grants from Astra Zeneca outside the submitted work. SR received institutional grants from Jazz Pharmaceuticals and consulting fees from Jazz Pharmaceuticals and Respicardia.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

An overview of the study design. AT, adenotonsillectomy; eAT, early adenotonsillectomy; ENT, Otolaryngology (ear, nose and throat); PSG, polysomnography; WWSC, watchful waiting with supportive care.