Prediction of Tongue Base Obstruction During Sleep

N/ARecruitingNCT06792045

Université Catholique de Louvain48 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Obstructive Sleep Disordered Breathing

Interventions

Physiotherapist assessmentOTHER

* 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.).

ENT assessmentOTHER

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

Drug-Induced Sleep EndoscopyDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Cliniques universitaires Saint-Luc

Brussels, Belgium

RECRUITING

Outcomes

Primary Outcomes

Extent of tongue base obstruction

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

Time frame: During the planned surgery

Secondary Outcomes

Breathing pattern

Presence or absence of mouth breathing will be assessed with the mouth breathing questionnaire from Abreu et al. (2018).

Time frame: During the pre-surgical appointment

Tongue mobility (MBLF score)

Assessed through the Motricité Bucco-Linguo-Faciale (MBLF) tongue test score

Time frame: During the pre-surgical appointment

Tongue pressures (kPa)

Tongue pressures will be measured with the Iowa Oral Performance Instrument (IOPI), in kPa, during a protrusion, an elevation, and a swallowing task.

Time frame: During the pre-surgical appointment

Tongue mobility restriction due to its frenulum ratio (%)

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.

Time frame: During the pre-surgical appointment

Central Contacts

William Poncin, Pr, Dr.

CONTACT

+32470592032 william.poncin@uclouvain.be

Pierre Cnockaert, PT

CONTACT

cnockaert.kine@gmail.com

Data from ClinicalTrials.gov

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