Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06792045

Prediction of Tongue Base Obstruction During Sleep

Tongue Motor Functions Assessment As a Screening Tool for Obstructive Sleep Disordered Breathing in Children

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
48 (estimated)
Sponsor
Université Catholique de Louvain · Academic / Other
Sex
All
Age
6 Years – 17 Years
Healthy volunteers
Not accepted

Summary

This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing.

Detailed description

Patients will be enrolled during their visit to the ENT physician. Subsequently, their tongue motor functions will be assessed during their pre-surgical appointment. Finally, they will undergo a drug-induced sleep endoscopy prior to their surgery.

Conditions

Interventions

TypeNameDescription
OTHERPhysiotherapist assessment* Tongue motor skills (Tongue pressures and tongue mobility, assessed through the Iowa Oral Performance Instrument and the Motricité Bucco-Linguo-Faciale tongue subscore, respectively) * Tongue restriction of mobility due to its frenulum (assessed through the Quick Tongue-Tie assessment tool) * Breathing Pattern (questionnaire from Abreu RR, Rocha RL, Lamounier JA, Guerra AF. Etiology, clinical manifestations and concurrent findings in mouth-breathing children. J Pediatr (Rio J). 2008;84(6):529-535.).
OTHERENT assessmentData from the ENT appointment will be collected (e.g., sex, height, weight)
DIAGNOSTIC_TESTDrug-Induced Sleep EndoscopyA Drug-Induced Sleep Endoscopy will be performed, recorded, and evaluated by two blinded raters using the IPSES scale.

Timeline

Start date
2025-04-01
Primary completion
2026-06-01
Completion
2026-09-01
First posted
2025-01-24
Last updated
2025-03-25

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT06792045. Inclusion in this directory is not an endorsement.