Continuous Positive Airway Pressure vs High Flow Nasal Cannula for the Treatment of OSA in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
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.
详细描述
Obstructive sleep apnea (OSA) is a common pediatric condition characterized by repeated episodes of upper airway obstruction during sleep. These episodes disrupt normal sleep patterns and oxygenation and are associated with significant short- and long-term health consequences. In children, untreated moderate-to-severe OSA has been linked to impaired quality of life, behavioral and emotional difficulties, impaired learning and school performance, cardiovascular and metabolic effects, and increased caregiver stress and health care utilization.
For many children, adenotonsillectomy is the first-line treatment; however, a substantial proportion continue to experience residual OSA after surgery or are not suitable surgical candidates. In these cases, Continuous Positive Airway Pressure (CPAP) therapy is the standard treatment. CPAP delivers pressurized air through a mask worn during sleep to keep the airway open. While CPAP is effective under optimal conditions, real-world effectiveness in pediatric populations is limited by low tolerance and adherence. Common challenges include discomfort related to the mask interface, claustrophobia, air pressure intolerance, and family burden associated with nightly device use.
High-Flow Nasal Cannula (HFNC) therapy has emerged as a potential alternative for treating pediatric OSA. HFNC delivers warmed, humidified air at high flow rates through soft nasal prongs and can generate positive airway pressure that supports upper airway patency. Compared with CPAP, HFNC may be perceived as less intrusive and more comfortable, which could improve adherence and overall treatment effectiveness. Preliminary physiologic studies and small clinical trials suggest that HFNC can reduce OSA severity; however, there is limited evidence comparing HFNC and CPAP in children, particularly over extended periods of use in home settings.
The CHOSA Trial was designed to address this evidence gap by directly comparing CPAP and HFNC in children with moderate-to-severe OSA who require non-surgical therapy. The study evaluates the real-world use of these therapies in the home environment, with a focus on treatment adherence as well as patient- and family-centered outcomes. By embedding the intervention within routine clinical care across multiple centers, the study aims to reflect typical pediatric sleep medicine practice and enhance the generalizability of its findings.
Participants receive comprehensive education and support to promote safe and effective use of their assigned therapy. Device setup, fitting, and optimization are performed by trained respiratory therapists, and treatment is titrated using standard sleep study procedures to ensure appropriate therapeutic settings. During the home treatment period, participants and caregivers receive ongoing clinical support consistent with usual care, including troubleshooting for comfort and usability concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants, caregivers, and care providers are not masked due to the visible and distinct nature of the assigned devices (CPAP vs High-Flow Nasal Cannula). Outcome assessment of the primary endpoint (therapy adherence) is conducted using objective device-generated data, and investigators are blinded to adherence results during the intervention period. No additional parties are masked.
入排标准
- 年龄范围
- 2 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •Uncontrolled gastroesophageal reflux and/or recurrent vomiting
- •Uncontrolled oral secretions
- •Prior use of CPAP or High-Flow Nasal Cannula therapy for treatment of obstructive sleep apnea within the previous 12 months
研究组 & 干预措施
Continuous Positive Airway Pressure (CPAP)
Participants assigned to this arm will receive Continuous Positive Airway Pressure (CPAP) therapy for the treatment of obstructive sleep apnea. CPAP delivers pressurized air through a mask worn during sleep to keep the airway open. Participants will use CPAP at home each night during sleep for a three-month intervention period, with device settings optimized based on standard clinical care.
干预措施: Continuous Positive Airway Pressure (Device)
High-Flow Nasal Cannula (HFNC)
Participants assigned to this arm will receive High-Flow Nasal Cannula (HFNC) therapy for the treatment of obstructive sleep apnea. HFNC delivers warmed, humidified air at high flow rates through soft nasal prongs to support airway patency during sleep. Participants will use HFNC at home each night during sleep for a three-month intervention period, with flow settings optimized based on standard clinical care.
干预措施: High Flow Nasal Cannula (Device)
结局指标
主要结局
Adherence
时间窗: 3 months
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.
次要结局
- OSA-Related Quality of Life(Baseline and 3 months)
- OSA Symptoms(Baseline and 3 months)
- Sleep Quality and Disturbance(Baseline and 3 months)
- Insomnia symptoms(Baseline and 3 months)
- Daytime Sleepiness(Baseline and 3 months)
- Health-related quality of life(Baseline and 3 months)
- Psychosocial Functioning(Baseline and 3 months)
- Perceived Comfort(3 months)
- Barriers to Therapy Use(3 months)
- Caregiver Stress and Burden(Baseline and 3 months)
- Self-efficacy(Baseline and 3 months)
- Self-report chronotype(Baseline and 3 months)
- Parent-report chronotype(Baseline and 3 months)
- Cost-effectiveness - Quality-Adjusted Life Year (QALY)(Baseline and 3 months)
- Cost-effectiveness - Cost Utility(3 months)
研究者
Indra Narang
VP, Health Equity and Inclusion
The Hospital for Sick Children
