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Prediction of Tongue Base Obstruction During Sleep (PTOS)

U

Université Catholique de Louvain

Status

Not yet enrolling

Conditions

Obstructive Sleep Disordered Breathing

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

Children with obstructive sleep disordered breathing
Treatment:
Other: ENT assessment
Other: Physiotherapist assessment
Diagnostic Test: Drug-Induced Sleep Endoscopy

Trial contacts and locations

1

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Central trial contact

William Poncin, Pr, Dr.; Pierre Cnockaert, PT

Data sourced from clinicaltrials.gov

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