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Recruiting
NCT05638087
Dexamethasone Treatment for OSA in Children
Conditions: Obstructive Sleep Apnea
Sex: All
Ages: 2 Years – 10 Years
Phase: PHASE3
Enrollment: 22
Sponsor: The Hospital for Sick Children
Location: Canada
Summary
This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG).
Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a treatment to manage the severity and symptoms in children with moderate to severe OSA.
Eligibility Criteria
Inclusion Criteria:Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour)Aged 2-10 yearsPresence of adenotonsillar hypertrophyAbility to take oral medication and be willing to adhere to the dosing regimenInformed consent provided in accordance with institutional policiesExclusion Criteria:Previous adenotonsillectomyPresence of symptoms of an upper respiratory tract infectionCo-existing central sleep apneaHypertensionPrior or current evidence for abnormal glucose toleranceContraindication for dexamethasone or components of dexamethasone oral suspension,Treatment with nasal or systemic corticosteroids within 4 weeks prior to the interventionOSA with associated oxygen desaturations <90% for 2 continuous minutesNeed for non-invasive ventilation long-term due to underlying diseaseCurrent systemic fungal infectionsPatients with clinically relevant varicella exposure
Source: ClinicalTrials.gov (NCT05638087). StuddyBuddy aggregates publicly available trial information.