ClinicalTrials.gg
RecruitingNCT06792045PTOSUpdated Nov 4, 2026

Prediction of Tongue Base Obstruction During Sleep

An observational study in Obstructive Sleep Disordered Breathing, sponsored by Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Université Catholique de Louvain · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Nov 4, 2026Eligibility revisedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
48
Ages
4 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Disordered Breathing

Keywords

  • obstructive sleep disordered breathing
  • pediatrics
  • sleep
  • obstructive sleep apnea
  • snoring
  • tongue
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 48 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 154 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 4, 2026. See what changed

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be recruited during ENT consultations.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 4 and 17 years old
  • Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids, excluding type III (e.g., linked to a neurological comorbidity)
  • Positive Pediatric Sleep Questionnaire (8 or more positive responses)
  • Eligibility for surgical intervention

Exclusion criteria

Exclusion Criteria:

  • Previous surgery of the upper airway or oral cavity
  • History of or current head or neck cancer
  • Cranial, upper airway, or oral cavity malformation
  • to performing the assessments
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
48 participants (estimated)
Patient registry
No

Groups and cohorts

  • Children with obstructive sleep disordered breathing

    Other: Physiotherapist assessment · Other: ENT assessment · Diagnostic Test: Drug-Induced Sleep Endoscopy

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)

  • Diagnostic testDrug-Induced Sleep Endoscopy

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Tongue mobility (MBLF score)

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

    Time frame: During the pre-surgical appointment

  3. 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

  4. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
Minimum age 6 Years→4 Years; 2 inclusion criteria edited; 1 exclusion criterion edited, 1 removed
What changed in the criteria
Inclusion criteria
  • EditedAge between 64 and 17 years old
  • EditedMedical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids, excluding type III (e.g., linked to a neurological comorbidity)
Exclusion criteria
  • RemovedNeurological, cardiac, or respiratory comorbidity other than obstructive sleep-disordered breathing
  • EditedContraindication to performing endoscopythe assessments
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Eligibility Minimum age 6 Years→4 Years; 2 inclusion criteria edited; 1 exclusion criterion edited, 1 removed
    What changed in the criteria
    Inclusion criteria
    • EditedAge between 64 and 17 years old
    • EditedMedical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids, excluding type III (e.g., linked to a neurological comorbidity)
    Exclusion criteria
    • RemovedNeurological, cardiac, or respiratory comorbidity other than obstructive sleep-disordered breathing
    • EditedContraindication to performing endoscopythe assessments
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06792045
Responsible party
William Poncin (Principal Investigator, Professor, Université Catholique de Louvain) — Principal investigator
First posted
Jan 24, 2025
Start date
Aug 22, 2025
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

William Poncin, Pr, Dr.
Contact
william.poncin@uclouvain.be
+32470592032
Pierre Cnockaert, PT
Contact
cnockaert.kine@gmail.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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