Prediction of Tongue Base Obstruction During Sleep

Not yet recruiting

• Conditions: Obstructive Sleep Disordered Breathing

• Registration Number: NCT06792045
• Lead Sponsor: Université Catholique de Louvain

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.

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.

Study Timeline

• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2025-01-19
• Study First Posted: 2025-01-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Start: 2025-04
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent of tongue base obstruction	During the planned surgery	Evaluated through the IPSES scoring during a Drug Induced Sleep Endoscopy (DISE)

Secondary Outcome Measures

Name	Time	Method
Breathing pattern	During the pre-surgical appointment	Presence or absence of mouth breathing will be assessed with the mouth breathing questionnaire from Abreu et al. (2018).
Tongue mobility (MBLF score)	During the pre-surgical appointment	Assessed through the Motricité Bucco-Linguo-Faciale (MBLF) tongue test score
Tongue pressures (kPa)	During the pre-surgical appointment	Tongue pressures will be measured with the Iowa Oral Performance Instrument (IOPI), in kPa, during a protrusion, an elevation, and a swallowing task.
Tongue mobility restriction due to its frenulum ratio (%)	During the pre-surgical appointment	The ratio between the maximal comfortable mouth opening, with the tongue tip to the incisive papilla, and the maximal comfortable mouth opening, will be computed.

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium