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Recruiting Not applicable

Tongue Muscular Assessment in Children With Sleep Disordered Breathing

NCT07273019 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-03-26
Last updated
2026-07-30

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Tongue Strength AssessmentPolysomnographySubjective Assessment of Sleep-Disordered BreathingSubjective Assessment of Daytime FunctioningAnthropometryClinical ExaminationOrofacial Praxis Assessment

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

Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant Bron France Recruiting
Official registry record

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