Prediction of Tongue Base Obstruction During Sleep
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physiotherapist assessment, ENT assessment, Drug-Induced Sleep Endoscopy.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Disordered Breathing. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Tongue Motor Functions Assessment as a Screening Tool for Obstructive Sleep Disordered Breathing in Children
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.
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
- 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- - 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.
Primary outcome measures
- Extent of tongue base obstruction [Time frame: During the planned surgery]
Secondary outcome measures (4)
- Breathing pattern [Time frame: During the pre-surgical appointment]
- Tongue mobility (MBLF score) [Time frame: During the pre-surgical appointment]
- Tongue pressures (kPa) [Time frame: During the pre-surgical appointment]
- Tongue mobility restriction due to its frenulum ratio (%) [Time frame: During the pre-surgical appointment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- Cliniques universitaires Saint-Luc — Brussels
Identifiers
NCT: NCT06792045 · PTOS