Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

17mo left

Started Mar 2026

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Progress8%

Mar 2026Sep 2027

First Submitted

Initial submission to the registry

November 19, 2025

Completed

20 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed

4 months until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

November 19, 2025

Last Update Submit

March 26, 2026

Conditions

Obstructive Sleep Apnea

Keywords

TongueMotor functionsSleepSleep apnea

Outcome Measures

Primary Outcomes (1)

Tongue peak pressure during protrusion
Tongue peak pressure during protrusion will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome.
Day 1

Secondary Outcomes (31)

Tongue peak pressure during elevation and swallowing
Day 1
Tongue mobility restriction
Day 1
Orofacial praxis
Day 1
Obstructive apnea-hypopnea index (OAHI)
Day 1
Central apnea-hypopnea index
Day 1
+26 more secondary outcomes

Study Arms (1)

Children referred for polysomnography for suspected OSA

EXPERIMENTAL

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

Other: Tongue Strength AssessmentDiagnostic Test: PolysomnographyOther: Subjective Assessment of Sleep-Disordered BreathingOther: Subjective Assessment of Daytime FunctioningOther: AnthropometryOther: Clinical ExaminationOther: Orofacial Praxis Assessment

Interventions

PolysomnographyDIAGNOSTIC_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.