ArticleBMJ open2025
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.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06973928 (Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy? The JawChild Prospective Cohort Study), which is not on this map. Not yet cited in PubMed.
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Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy? The JawChild Prospective Cohort Study
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7 authors.
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Abstract
introductionAdenotonsillectomy 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.
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