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.
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)
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
Parallel
High Flow Nasal Cannula
DeviceHigh-Flow Nasal Cannula (HFNC) therapy delivers warmed, humidified air at high flow rates through soft nasal prongs during sleep to support upper airway patency in children with obstructive sleep apnea. The therapy is used nightly at home, with flow settings optimized according to standard clinical care and overnight sleep study titration.
Continuous Positive Airway Pressure
DeviceContinuous Positive Airway Pressure (CPAP) therapy delivers pressurized air through a nasal or oronasal mask worn during sleep to maintain upper airway patency and treat obstructive sleep apnea. CPAP therapy is used nightly at home, with pressure settings optimized according to standard clinical care and overnight sleep study titration.
Adherence
Adherence is defined as the average number of hours and minutes of CPAP or High-Flow Nasal Cannula use per night, obtained from objective device-generated data over the intervention period.
OSA-Related Quality of Life
Change from baseline to post-intervention follow-up in obstructive sleep apnea (OSA)-related quality of life, measured using the OSA-18 questionnaire. \[Total score ranges from 18 to 126. A higher score indicates greater negative impact of OSA on the child's quality of life\]
OSA Symptoms
Change from baseline to post-intervention follow-up in obstructive sleep apnea symptoms, measured using the Pediatric Sleep Questionnaire (PSQ). \[Total score ranges from 0 to 1. A higher score indicates a greater frequency and severity of sleep-disordered breathing symptoms\]
Sleep Quality and Disturbance
Change from baseline to post-intervention follow-up in sleep quality and sleep disturbance, measured using the Sleep Disturbance Scale for Children (SDSC). Total score ranges from 26 to 130. A higher scores indicates a higher degree of sleep disturbances.
Insomnia symptoms
Change from baseline to post-intervention follow-up in insomniac symptoms, measured using insomnia severity index (ISI). The total score ranges from 0 to 28, with a higher score indicating more severe insomnia symptoms, greater sleep distress, and worse daytime impairment
Participant and Caregiver Experience With Therapy
Experiences with CPAP and High-Flow Nasal Cannula therapy, including comfort, perceived benefits and challenges, adherence strategies, and caregiver impact, assessed through semi-structured qualitative interviews.
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The Hospital for Sick Children
Lead sponsor
Fisher and Paykel Healthcare
Collaborator
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