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NCT Number: NCT06792045

Prediction of Tongue Base Obstruction During Sleep

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.

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Key information

Conditions

Obstructive Sleep Disordered Breathing Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location status: Recruiting

Location contact

William Poncin, Pr., Dr.

CONTACT

[email protected]

+32470592032

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapist assessment

Other
  • 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 assessment

Other

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

Drug-Induced Sleep Endoscopy

Diagnostic Test

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

Primary outcomes

  1. Extent of tongue base obstruction

    Time frame: During the planned surgery

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

Secondary outcomes

  1. Breathing pattern

    Time frame: During the pre-surgical appointment

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

  2. Tongue mobility (MBLF score)

    Time frame: During the pre-surgical appointment

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

  3. Tongue pressures (kPa)

    Time frame: During the pre-surgical appointment

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

  4. Tongue mobility restriction due to its frenulum ratio (%)

    Time frame: During the pre-surgical appointment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Cnockaert, PT

CONTACT

[email protected]

William Poncin, Pr, Dr.

CONTACT

[email protected]

+32470592032

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: PTOS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 24, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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