Tongue Muscular Assessment in Children With Sleep Disordered Breathing

Sponsor
Hospices Civils de Lyon
Study ID
NCT07273019
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
4 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Tongue Strength Assessment — OTHER
    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 — DIAGNOSTIC_TEST
    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 — OTHER
    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 — OTHER
    The following questionnaires will be filled out: * Epworth Sleepiness Scale * Conners
  • Anthropometry — OTHER
    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 — OTHER
    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 — OTHER
    Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).

Study Details

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.

Key Dates

First listed
Dec 9, 2025
Start date
Mar 26, 2026
Status verified
Mar 2026
Primary completion
Sep 26, 2027
Completion
Sep 26, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Children referred for polysomnography for suspected OSA
    Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA

Primary Outcome Measure

Tongue peak pressure during protrusion [ Time Frame: Day 1 ]

Central Contacts

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