Measuring tongue muscle function in children with obstructive sleep apnea
Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea
NA · Hospices Civils de Lyon · NCT07273019
This project tests tongue strength and movement in children with suspected obstructive sleep apnea to see if tongue function contributes to breathing problems during sleep.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Bron) |
| Trial ID | NCT07273019 on ClinicalTrials.gov |
What this trial studies
This interventional study measures tongue motor function in children referred for polysomnography for suspected sleep-disordered breathing and compares results with healthy children from a concurrent TMAC dataset. Participants undergo overnight polysomnography, quantitative tongue strength and motor testing, standardized questionnaires about sleep and daytime functioning, and anthropometric measurements. Investigators will compare motor function metrics between children with OSA and healthy controls to identify myofunctional deficits linked to persistent obstruction. The goal is to clarify the tongue's role in pediatric OSA and inform targeted therapeutic approaches.
Who should consider this trial
Good fit: Children referred for polysomnography with suspected sleep-disordered breathing who have informed consent from both legal guardians, understand French, and are affiliated to a social security scheme.
Not a fit: Children with major neurological, cardiac, or respiratory disorders, prior upper-airway or oral surgery, craniofacial malformations, intellectual deficits preventing cooperation, or insufficient French comprehension are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help identify tongue-related causes of persistent OSA in children and guide targeted treatments such as myofunctional therapy or tailored surgical planning.
How similar studies have performed: Previous work indicates the tongue can be a site of airway obstruction and some myofunctional therapy studies show benefit, but direct pediatric tongue motor testing is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 respiratory conditions other than sleep disorders and their repercussions * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition) * Previous surgery performed on the upper airway or the oral cavity * 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
Where this trial is running
Bron
- Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant — Bron, France (RECRUITING)
Study contacts
- Study coordinator: Patricia FRANCO, MD, PhD
- Email: patricia.franco@chu-lyon.fr
- Phone: +33 4 27 85 60 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, Tongue, Motor functions, Sleep, Sleep apnea