NCT07273019 Tongue Muscular Assessment in Children With Sleep Disordered Breathing
| NCT ID | NCT07273019 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2026-03-26 |
| Primary Completion | 2027-09-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2026-03-26 with a primary completion date of 2027-09-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07273019 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07273019 currently recruiting?
Yes, NCT07273019 is actively recruiting participants. Contact the research team at patricia.franco@chu-lyon.fr for enrollment information.
Where is the NCT07273019 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT07273019 clinical trial?
NCT07273019 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 78 participants.