Clinical Trial

Tongue Muscular Assessment in Children With Sleep Disordered Breathing

Study acronym: TMAC-C
Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-09-26 -> 2028-03-26 2026-07-31
minor Completion pushed: 2027-09-26 -> 2028-03-26 2026-07-31
Trial Details
NCT Number NCT07273019
Lead Sponsor Hospices Civils de Lyon
Conditions Obstructive Sleep Apnea
Enrollment 78 participants
Start Date 2026-03-26
Primary Completion 2028-03-26 (estimated)
Study Completion 2028-03-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-30