Dexamethasone Treatment for OSA in Children (NCT05638087) | Clinical Trial Compass
CompletedPhase 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 range
2 Years – 10 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.