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Tongue Muscular Assessment in Children With Sleep Disordered Breathing

RecruitingNAAges 4 Years - 17 YearsAllHospices Civils de Lyon
NCT07273019 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing. The primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to com

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📋 Eligibility rules (as published)
Inclusion Criteria: * With suspected sleep-disordered breathing * Referred for polysomnography * Affiliated to a social security scheme * With informed consent from both legal representatives Exclusion Criteria: * Insufficient comprehension of French language * Regarding patients with suspected OSA type I or II: * Neurological, cardiac, or unstable respiratory conditions other than sleep disorders and their repercussions * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition) * Malformation of the skull, the upper airway or the oral cavity * Regarding patients with suspected OSA type III: * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition) * Intellectual deficit impeding the understanding of instructions
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What it tests

  • Tongue Strength Assessment
  • Polysomnography
  • Subjective Assessment of Sleep-Disordered Breathing
  • Subjective Assessment of Daytime Functioning
  • Anthropometry
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Where

1 site
Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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