Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
48 participants
OBSERVATIONAL
2025-04-30
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Children with obstructive sleep disordered breathing
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):529-535.).
ENT assessment
Data from the ENT appointment will be collected (e.g., sex, height, weight)
Drug-Induced Sleep Endoscopy
A Drug-Induced Sleep Endoscopy will be performed, recorded, and evaluated by two blinded raters using the IPSES scale.
Interventions
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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):529-535.).
ENT assessment
Data from the ENT appointment will be collected (e.g., sex, height, weight)
Drug-Induced Sleep Endoscopy
A Drug-Induced Sleep Endoscopy will be performed, recorded, and evaluated by two blinded raters using the IPSES scale.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
17 Years
ALL
No
Sponsors
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Université Catholique de Louvain
OTHER
Responsible Party
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William Poncin
Principal Investigator, Professor
Locations
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Cliniques universitaires Saint-Luc
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PTOS
Identifier Type: -
Identifier Source: org_study_id
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