Prediction of Tongue Base Obstruction During Sleep (PTOS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Disordered Breathing
• Intervention / Treatment: Other: Physiotherapist assessment; Other: ENT assessment; Diagnostic test: Drug-Induced Sleep Endoscopy

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 Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: William Poncin, Pr, Dr.; Phone Number: +32470592032; Email: william.poncin@uclouvain.be
• Study Contact Backup: Name: Pierre Cnockaert, PT; Email: cnockaert.kine@gmail.com

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-luc
    • Contact: William Poncin, Pr., Dr.; Phone Number: +32470592032; Email: william.poncin@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited during ENT consultations.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children with obstructive sleep disordered breathing

Other: Physiotherapist 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.).; Other: ENT assessment; Data from the ENT appointment will be collected (e.g., sex, height, weight); Diagnostic test: Drug-Induced Sleep Endoscopy; A Drug-Induced Sleep Endoscopy will be performed, recorded, and evaluated by two blinded raters using the IPSES scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of tongue base obstruction	Evaluated through the IPSES scoring during a Drug Induced Sleep Endoscopy (DISE)	During the planned surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing pattern	Presence or absence of mouth breathing will be assessed with the mouth breathing questionnaire from Abreu et al. (2018).	During the pre-surgical appointment
Tongue mobility (MBLF score)	Assessed through the Motricité Bucco-Linguo-Faciale (MBLF) tongue test score	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.	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.	During the pre-surgical appointment

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; snoring; sleep; obstructive sleep apnea; tongue; obstructive sleep disordered breathing
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Respiratory Sounds; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Apnea, Obstructive; Snoring
• Other Study ID Numbers: PTOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No