Tongue Muscular Assessment in Children With Sleep Disordered Breathing

NCT07273019 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

Interventions

OTHER

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

DIAGNOSTIC_TEST

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.

OTHER

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

OTHER

Subjective Assessment of Daytime Functioning

The following questionnaires will be filled out: * Epworth Sleepiness Scale * Conners

OTHER

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

OTHER

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

OTHER

Orofacial Praxis Assessment

Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2027-09-26
Completion
2027-09-26

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273019 on ClinicalTrials.gov