Tongue Muscular Assessment in Children With Sleep Disordered Breathing
NCT07273019 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2026-03-27
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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