About this trial
This study is looking at two different treatments for obstructive sleep apnea (OSA) in children. OSA is a sleep condition where breathing repeatedly stops and starts during sleep, which can affect a child's health, behavior, learning, and quality of life.
Children with moderate-to-severe OSA who cannot be treated with surgery are often prescribed Continuous Positive Airway Pressure (CPAP). CPAP uses a mask worn during sleep to deliver pressurized air and keep the airway open. Although CPAP is effective, many children have difficulty using it regularly because it can feel uncomfortable or hard to tolerate.
This study compares CPAP with another treatment called High-Flow Nasal Cannula (HFNC). HFNC delivers warm, humidified air through soft nasal prongs and may be more comfortable and easier for children to use while still helping keep the airway open during sleep.
Children aged 2 to 18 years with moderate-to-severe OSA will be randomly assigned to use either CPAP or HFNC at home during sleep for 3 months. The study will measure how much each treatment is used, how well it improves sleep-related symptoms and quality of life, how comfortable it is for children, and how it affects caregivers.
The goal of this study is to find out whether HFNC is a comfortable and effective alternative to CPAP for treating obstructive sleep apnea in children.
Eligibility criteria
Qualifiers
Aged 2 to 18 years
Diagnosed with moderate to severe obstructive sleep apnea, defined as an obstructive apnea-hypopnea index (OAHI) ≥5 events/hour, confirmed by an in-laboratory polysomnography within the previous 6 months
Deemed to require Continuous Positive Airway Pressure (CPAP) therapy as part of usual clinical care
Ability of the participant and/or parent or legal guardian to provide informed consent (and assent when applicable)
Disqualifiers
Predominant or pathological central sleep apnea (central apnea-hypopnea index ≥5 events/hour)
Chronic respiratory failure or medical conditions requiring ventilatory support with a set respiratory rate (e.g., neuromuscular disease requiring bilevel ventilation with a backup rate)
Hypoventilation requiring non-invasive ventilation with a set respiratory rate
History of pneumothorax or pneumomediastinum
Trial design
Treatments tested in this trial
- High Flow Nasal Cannula
- Continuous Positive Airway Pressure
Treatment groups
Sponsors and collaborators
The Hospital for Sick Children
Lead sponsor
Fisher and Paykel Healthcare
Collaborator