Tongue Muscular Assessment in Children With Sleep Disordered Breathing
Condition(s) studied
Investigational drug(s) / intervention(s)
Tongue Strength Assessment: The following items will be assessed: 1. Tongue peak pressure during 3 seconds of tongue protrusion 2. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 seconds of tongue elevation 3. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing
Polysomnography: Patients will undergo full-night polysomnography (including the JAWAC system to record mandibular movements) in the sleep unit of Hôpital Femme-Mère-Enfant (Bron, France) to explore OSA.
Subjective Assessment of Sleep-Disordered Breathing: The following questionnaires will be filled out: * OSA-18 * Pediatric Sleep Questionnaire (PSQ) * Spruyt \& Gozal * Sleep Disturbance Scale for Children * Abreu et al.'s questionnaire
Subjective Assessment of Daytime Functioning: The following questionnaires will be filled out: * Epworth Sleepiness Scale * Conners
Anthropometry: The following measures will be collected via the Quick Tongue-Tie Assessment tool: 1. Maximal mouth opening 2. Maximal mouth opening with tongue to palate
Clinical Examination: The following variables will be collected during a clinical examination: 1. Age 2. Sex 3. Weight 4. Height 5. BMI 6. Friedman score 7. Mallampati score 8. Medical history
Orofacial Praxis Assessment: Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).
Study 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
Primary outcome measure(s)
- Tongue peak pressure during protrusion — Day 1
Tongue peak pressure during protrusion will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant | Bron | France | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07273019 on ClinicalTrials.gov ↗ ← All trials in France