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CompletedPhase 3

Dexamethasone Treatment for OSA in Children

Key facts

Who runs it
The Hospital for Sick Children
Where
Canada1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
10 people enrolled
Started
26 Oct 2022
Ended
30 Dec 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Dexamethasone
  • Placebo Control
Record updated
12 May 2026

Who can take part

Age
2 years to 10 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour)
  • Aged 2-10 years
  • Presence of adenotonsillar hypertrophy
  • Ability to take oral medication and be willing to adhere to the dosing regimen
  • Informed consent provided in accordance with institutional policies

Who cannot take part

  • Previous adenotonsillectomy
  • Contraindication for dexamethasone or components of dexamethasone oral suspension,
  • Treatment with nasal or systemic corticosteroids within 4 weeks prior to the intervention
  • Presence of symptoms of an upper respiratory tract infection
  • Hypertension
  • Need for non-invasive ventilation long-term due to underlying disease
  • Current systemic fungal infections
  • Prior or current evidence for abnormal glucose tolerance
  • Co-existing central sleep apnea
  • OSA with associated oxygen desaturations <90% for 2 continuous minutes
  • Patients with clinically relevant varicella exposure

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Dexamethasone TreatmentTreatment being tested

    Oral Dexamethasone treatment

    Treatment: Dexamethasone

  • Placebo TreatmentPlacebo, for comparison

    Placebo control

    Treatment: Placebo Control

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Dexamethasone as a Novel Treatment for Obstructive Sleep Apnea in Children
Record updated
12 May 2026