Active — Not RecruitingPhase 3

Dexamethasone Treatment for OSA in Children

Canada10 participantsStarted 2022-10-26

Plain-language 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.

Who can participate

Age range2 Years – 10 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Obstructive apnea-hypopnea index

Timeframe: Baseline and 2-4 weeks

Trial details

NCT IDNCT05638087

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-21

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials