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Publications

Journal Article Clinical Trial Protocol Epublish

PubMed: 41397757 DOI: 10.1136/bmjopen-2025-105324

Is a change in mouth opening associated with improvements in quality of life in children with type 1 obstructive sleep apnoea after adenotonsillectomy? Protocol for the JawChild prospective cohort study.

BMJ Open 15(12):e105324

Authors: Mohamed Akkari, Régis Lopez, Isabelle Jaussent, Célia Vidal, Sarah Skinner, Dany Jaffuel, Nicolas Molinari

Affiliations

  • Clinique Saint Jean, Montpellier, France.
  • Institute of Neurosciences of Montpellier INM, University of Montpellier, INSERM, Montpellier, France.
  • IDESP, INSERM, PreMEdical INRIA, Univ Montpellier, CHU Montpellier, Montpellier, France.
  • Service d'Information Médicale, Épidémiologie et Données de Santé, CHU Montpellier, Montpellier, France.
  • PhyMedExp (INSERM U 1046, CNRS UMR9214), Montpellier University, Montpellier, France.

Abstract

INTRODUCTION

Adenotonsillectomy is the primary treatment for type 1 obstructive sleep apnoea (OSA1). Although polysomnography (PSG) remains the gold standard for measuring Apnoea-Hypopnoea Index, it is a labour-intensive procedure and does not correlate with improvements in quality of life postadenotonsillectomy. Mouth breathing is associated with poorer quality of life in children. Mandibular movement (MM), which measures mouth opening, is a validated measure of respiratory effort that can be easily and safely assessed in children using the JAWAC technology. This study aims to evaluate the relationship between changes in quality of life and changes in mouth opening in children with OSA1 after undergoing adenotonsillectomy. Secondary objectives include evaluating changes in quality of life, clinical symptoms and other MM and PSG metrics in the same population.

METHODS AND ANALYSIS

This exploratory, non-randomised, monocentric, prospective cohort study with a non-blinded single arm will include 50 children aged 3-7 years, undergoing adenotonsillectomy at the Clinique Saint Jean, Montpellier, France. Quality of life will be measured using the parent version of the Paediatric Quality of Life Inventory and MM metrics will be measured during PSG using the JAWAC system during the inclusion visit and 3 months after adenotonsillectomy. The primary outcome will be the correlation between the changes in quality of life and mouth opening (1/10 mm) postadenotonsillectomy. Secondary analyses will evaluate changes in clinical symptoms, PSG measures and other MM metrics including respiratory effort, as well as the associations between these measures.

ETHICS AND DISSEMINATION

This study was approved by an independent ethics committee (Comité de Protection des Personnes Est) on 24 March 2025 (2024-A02761-46) and will be conducted in accordance with French law, good clinical practice and the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.

TRIAL REGISTRATION NUMBER

NCT06973928.

MeSH

Quality Of Life, Sleep, Cohort Studies, Signs And Symptoms, Physical Exertion, Mouth, Child