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Prediction of Tongue Base Obstruction During Sleep

ConditionObstructive Sleep Disordered Breathing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorUniversité Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Participants will be recruited during ENT consultations.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Physiotherapist assessment

    Other intervention

    * 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 intervention

    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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Children with obstructive sleep disordered breathing3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université Catholique de Louvain

Lead sponsor

Source ClinicalTrials.gov
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