CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in Children (CHOSA)

Continuous Positive Airway Pressure vs High Flow Nasal Cannula for the Treatment of OSA in Children

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: Continuous Positive Airway Pressure; Device: High Flow Nasal Cannula

Detailed Description

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.

The primary focus of the study is adherence to therapy, assessed using objective device data. Secondary aspects of the study evaluate the broader impact of treatment on sleep-related symptoms, quality of life, comfort, psychosocial functioning, caregiver burden, and health economic outcomes using validated instruments. These outcomes were selected to capture not only physiological effectiveness, but also the acceptability and practicality of each treatment from the perspective of children and families.

A qualitative component is incorporated to provide a deeper understanding of participant and caregiver experiences. Through semi-structured interviews, the study explores perceived benefits and challenges of CPAP and HFNC, factors influencing nightly use, strategies families employ to support adherence, and the impact of therapy on daily routines and well-being. This qualitative information complements quantitative findings and helps contextualize adherence and outcome data.

Both CPAP and HFNC are commonly used non-invasive respiratory therapies with established safety profiles in pediatric care. Safety monitoring is conducted throughout the study, and adverse events are documented in accordance with ethical and regulatory requirements. Participation is voluntary, and families may withdraw at any time without affecting the child's clinical care.

By comparing CPAP and HFNC in a large, diverse pediatric population using real-world home use conditions, the CHOSA Trial aims to inform clinical decision-making and guideline development. The results are expected to clarify whether HFNC offers a more acceptable or effective alternative for children who struggle with standard CPAP therapy and to support evidence-based expansion of treatment options for pediatric obstructive sleep apnea.

• Study Type: Interventional
• Enrollment (Estimated): 258
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aditi Garg; Phone Number: (416) 813 6809; Email: aditi.garg@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children
      • Contact: Aditi Garg; Phone Number: (416) 813 6809; Email: aditi.garg@sickkids.ca
      • Principal Investigator: Indra Narang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Continuous Positive Airway Pressure; Continuous 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.
Experimental: 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.	Device: High Flow Nasal Cannula; High-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	Baseline and 3 months
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]	Baseline and 3 months
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.	Baseline and 3 months
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	Baseline and 3 months
Daytime Sleepiness	Change from baseline to post-intervention follow-up in daytime sleepiness, measured using the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD). The total score ranges from 0 to 24, with a higher score indicating more severe daytime sleepiness.	Baseline and 3 months
Health-related quality of life	Change from baseline in KIDSCREEN-10 index, a self-report health-related quality of life scale. Total score ranges from 10-50, with a higher score indicating better quality of life.	Baseline and 3 months
Psychosocial Functioning	Change from baseline to post-intervention follow-up in psychosocial functioning, measured using age-appropriate versions of the Strengths and Difficulties Questionnaire (SDQ). [Total score range from 0 to 40. A higher score indicates a higher level of psychological distress or behavioral problems.]	Baseline and 3 months
Perceived Comfort	Perceived comfort of using CPAP or High-Flow Nasal Cannula therapy, measured using comfort questionnaires.	3 months
Barriers to Therapy Use	Facilitators and barriers to use of continuous positive airway pressure (CPAP) or High-Flow Nasal Cannula (HFNC) therapy, measured using the Adherence Barriers to CPAP/HFNC Questionnaire. Total score ranges from 31 to 155, with a higher score indicating a larger barriers to adhere to the therapy.	3 months
Caregiver Stress and Burden	Change from baseline to post-intervention follow-up in caregiver stress and burden, measured using validated caregiver strain questionnaires. [Total score range from 11 to 55. A higher score indicates greater caregiver strain, burden, and distress.]	Baseline and 3 months
Self-efficacy	Self-Efficacy Measure for Sleep Apnea (SEMSA) is used to assess the willingness and confidence to engage in therapy despite potential obstacles. Total score ranges from 22-88. A higher score indicates higher levels of self-efficacy beliefs regarding their therapy for OSA.	Baseline and 3 months
Self-report chronotype	The circadian phase preference (chronotype) is assessed by reduced morningness-eveningness questionnaire (rMEQ). Total score ranges from 4 to 26. Higher scores (18-26) indicate a morning type, while lower scores (4-11) indicate an evening type (owl), and 12-17 being intermediate.	Baseline and 3 months
Parent-report chronotype	The circadian phase preference (chronotype) is assessed by a parent-reported instrument, the Children's ChronoType Questionnaire (CCTQ). Total score ranges from 10 to 48, with higher scores indicate greater eveningness, while lower scores indicate stronger morningness. Categories: <=23: Morning type; 24-32: Intermediate type; >=33: Evening type	Baseline and 3 months
Cost-effectiveness - Quality-Adjusted Life Year (QALY)	Quality-Adjusted Life Year (QALY) is a standard metric used in health economics to measure the benefit of medical treatments by combining both the quality and quantity of life lived. One QALY equals one year of life in perfect health. It is used to compare cost-effectiveness between HFNC and CPAP. QALY gained will be calculated from changes in patient utility, measured by the Health Utilities Index Mark 3 (HUI3), a comprehensive, multi-attribute system used to measure generic health status and health-related quality of life. It calculates a numerical health utility score-typically between 0.00 (dead) and 1.00 (perfect health).	Baseline and 3 months
Cost-effectiveness - Cost Utility	Cost utility of HFNC compared with CPAP, assessed by the incremental cost-effectiveness ratio (ICER), derived by dividing the incremental costs between HFNC and CPAP by the incremental quality-adjusted life years (QALY) gains.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at end of intervention of 3 month

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Indra Narang, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; quality of life; adherence; children; obstructive sleep apnea; adolescents; CPAP; Sleep-disordered breathing; HFNC; continuous positive airway pressure; High Flow nasal cannula; pediatric obstructive sleep apnea; home sleep therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Therapeutics; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure
• Other Study ID Numbers: 5447; 198152 (Other Grant/Funding Number: CIHR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) that are de-identified will be shared upon reasonable request and subject to approval by the study investigators, applicable institutional policies, and data-sharing agreements. IPD sharing may be limited or delayed to protect participant privacy, respect consent provisions, and allow for completion of planned primary and secondary analyses. Data will only be shared for scientifically sound research proposals and in accordance with ethical, legal, and regulatory requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No