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
Jessie P. Bakker,
Ronald D. Chervin,
Susan L. Garetz,
Fauziya Hassan,
Stacey L. Ishman,
Ron B. Mitchell,
Michael G. Morrical,
Syed K. Naqvi,
Jerilynn Radcliffe,
Emily I. Riggan,
Carol L. Rosen,
Kristie Ross,
Michael Rueschman,
Ignacio E. Tapia,
H. Gerry Taylor,
David A. Zopf
Affiliations
Jessie P. Bakker
Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA
Ronald D. Chervin
Sleep Disorders Center and Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA
Susan L. Garetz
Sleep Disorders Center and Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA
Fauziya Hassan
Sleep Disorders Center and Division of Pediatric Pulmonology, University of Michigan, Ann Arbor, Michigan, USA
Stacey L. Ishman
Divisions of Otolaryngology-Head and Neck Surgery and Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
Ron B. Mitchell
Department of Otolaryngology, Head and Neck Surgery, UT Southwestern and Children's Medical Center Dallas, Dallas, Texas, USA
Michael G. Morrical
Division of Sleep Medicine and Circadian Disorders, Brigham and Women’s Hospital, Boston, Massachusetts, USA
Syed K. Naqvi
Department of Otolaryngology, Head and Neck Surgery, UT Southwestern and Children's Medical Center Dallas, Dallas, Texas, USA
Jerilynn Radcliffe
Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
Emily I. Riggan
Department of Otolaryngology, Eastern Virginia Medical School, Norfolk, Virginia, USA
Carol L. Rosen
Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Kristie Ross
Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Michael Rueschman
Division of Sleep Medicine and Circadian Disorders, Brigham and Women’s Hospital, Boston, Massachusetts, USA
Ignacio E. Tapia
Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
H. Gerry Taylor
Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
David A. Zopf
Sleep Disorders Center and Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA
IntroductionMild 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 analysisThe 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 disseminationThe 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 numberNCT02562040; Pre-results.
