Dexamethasone Treatment for OSA in Children

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Previous adenotonsillectomy

• Presence of symptoms of an upper respiratory tract infection

• Co-existing central sleep apnea

• Hypertension

• Prior or current evidence for abnormal glucose tolerance

• Contraindication for dexamethasone or components of dexamethasone oral suspension,

• Treatment with nasal or systemic corticosteroids within 4 weeks prior to the intervention

• OSA with associated oxygen desaturations <90% for 2 continuous minutes

• Need for non-invasive ventilation long-term due to underlying disease

• Current systemic fungal infections

• Patients with clinically relevant varicella exposure