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Prediction of Tongue Base Obstruction During Sleep

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06792045
Acronym
PTOS
Enrollment
48
Registered
2025-01-24
Start date
2025-08-22
Completion date
2027-10-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Disordered Breathing

Keywords

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

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.

Interventions

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 assessment

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

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

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Extent of tongue base obstructionDuring the planned surgeryEvaluated through the IPSES scoring during a Drug Induced Sleep Endoscopy (DISE)

Secondary

MeasureTime frameDescription
Breathing patternDuring the pre-surgical appointmentPresence 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 appointmentAssessed through the Motricité Bucco-Linguo-Faciale (MBLF) tongue test score
Tongue pressures (kPa)During the pre-surgical appointmentTongue 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 appointmentThe ratio between the maximal comfortable mouth opening, with the tongue tip to the incisive papilla, and the maximal comfortable mouth opening, will be computed.

Countries

Belgium

Contacts

CONTACTWilliam Poncin, Pr, Dr.
william.poncin@uclouvain.be+32470592032
CONTACTPierre Cnockaert, PT
cnockaert.kine@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026