Prediction of Tongue Base Obstruction During Sleep

NCT06792045 | Recruiting

• 1 other identifier: PTOS
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Disordered Breathing

Keywords

obstructive sleep disordered breathing; pediatrics; sleep; obstructive sleep apnea; snoring; tongue

Outcome Measures

Primary Outcomes (1)

• Extent of tongue base obstruction

  Evaluated through the IPSES scoring during a Drug Induced Sleep Endoscopy (DISE)

  During the planned surgery

Secondary Outcomes (4)

• Breathing pattern

  During the pre-surgical appointment

• Tongue mobility (MBLF score)

  During the pre-surgical appointment

• Tongue pressures (kPa)

  During the pre-surgical appointment

• Tongue mobility restriction due to its frenulum ratio (%)

  During the pre-surgical appointment

Study Arms (1)

Children with obstructive sleep disordered breathing

Other: Physiotherapist assessment; Other: ENT assessment; Diagnostic Test: Drug-Induced Sleep Endoscopy

Interventions

Physiotherapist assessment OTHER

* 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.).

Children with obstructive sleep disordered breathing

ENT assessment OTHER

Data from the ENT appointment will be collected (e.g., sex, height, weight)

Children with obstructive sleep disordered breathing

Drug-Induced Sleep Endoscopy DIAGNOSTIC_TEST

A Drug-Induced Sleep Endoscopy will be performed, recorded, and evaluated by two blinded raters using the IPSES scale.

Children with obstructive sleep disordered breathing

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited during ENT consultations.

You may qualify if:

• Age between 6 and 17 years old
• Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids
• Positive Pediatric Sleep Questionnaire (8 or more positive responses)
• Eligibility for surgical intervention

You may not qualify if:

• Neurological, cardiac, or respiratory comorbidity other than obstructive sleep-disordered breathing
• Previous surgery of the upper airway or oral cavity
• History of or current head or neck cancer
• Cranial, upper airway, or oral cavity malformation
• Contraindication to performing endoscopy

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

William Poncin, Pr, Dr.

CONTACT

+32470592032; william.poncin@uclouvain.be

Pierre Cnockaert, PT

CONTACT

cnockaert.kine@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 24, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)