Dexamethasone for Obstructive Sleep Apnea in Children
Trial Summary
What is the purpose of this trial?
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.
Research Team
Indra Narang, MD
Principal Investigator
The Hospital for Sick Children
Eligibility Criteria
This trial is for children aged 2-10 with moderate to severe obstructive sleep apnea, who can take oral medication and have adenotonsillar hypertrophy. It's not for kids who've had an adenotonsillectomy, need long-term ventilation, have central sleep apnea or a current infection, hypertension, abnormal glucose tolerance, recent steroid treatment, oxygen issues during sleep or exposure to varicella.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 3-day course of oral dexamethasone or placebo
Follow-up
Participants return for follow-up visits to assess treatment efficacy and safety
Extended Follow-up
Participants return for a third study visit if no adenotonsillectomy is performed within 6 months
Treatment Details
Interventions
- Dexamethasone
- Placebo Control
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Hospital for Sick Children
Lead Sponsor