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

Rui Wang; 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; Susan Redline

doi:10.1136/bmjopen-2019-033889

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

BMJ Open. 2020 Mar 15;10(3):e033889. doi: 10.1136/bmjopen-2019-033889.

Authors

Rui Wang^{1

2}, Jessie P Bakker³, Ronald D Chervin⁴, Susan L Garetz⁵, Fauziya Hassan⁶, Stacey L Ishman^{7

8}, Ron B Mitchell⁹, Michael G Morrical¹⁰, Syed K Naqvi⁹, Jerilynn Radcliffe^{11

12}, Emily I Riggan¹³, Carol L Rosen¹⁴, Kristie Ross¹⁴, Michael Rueschman¹⁰, Ignacio E Tapia^{11

15}, H Gerry Taylor^{14

16}, David A Zopf⁵, Susan Redline³

Affiliations

¹ Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, USA [email protected].
² Department of Biostatistics, Harvard University T. H. Chan School of Public Health, Boston, Massachusetts, USA.
³ Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
⁴ Sleep Disorders Center and Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA.
⁵ Sleep Disorders Center and Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.
⁶ Sleep Disorders Center and Division of Pediatric Pulmonology, University of Michigan, Ann Arbor, Michigan, USA.
⁷ Divisions of Otolaryngology-Head and Neck Surgery and Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
⁸ Department of Otolaryngology-Head and Neck Surgery, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
⁹ Department of Otolaryngology, Head and Neck Surgery, UT Southwestern and Children's Medical Center Dallas, Dallas, Texas, USA.
¹⁰ Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital, Boston, Massachusetts, USA.
¹¹ Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
¹² Center for Human Phenomic Science, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
¹³ Department of Otolaryngology, Eastern Virginia Medical School, Norfolk, Virginia, USA.
¹⁴ Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
¹⁵ Division of Pulmonary Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
¹⁶ Department of Pediatrics, Abigail Wexner Research Institute at Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio, USA.

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.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Adenoidectomy*
Child
Child, Preschool
Humans
Multicenter Studies as Topic
Polysomnography
Randomized Controlled Trials as Topic
Sleep Apnea, Obstructive* / surgery
Snoring / surgery*
Tonsillectomy*

Associated data

ClinicalTrials.gov/NCT02562040

Abstract

Publication types

MeSH terms

Associated data

Grants and funding