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Obstructive Sleep Apnea (OSA)CHOSANCT07600333

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

A study testing High Flow Nasal Cannula and Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea (OSA), run by The Hospital for Sick Children at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Obstructive Sleep Apnea (OSA)
What is being tested?
High Flow Nasal Cannula and Continuous Positive Airway Pressure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
1 siteCanada
Study dates
1 Jun 2026to Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • The Hospital for Sick Children

    Toronto, Ontario

    Aditi Garg, (416) 813 6809, aditi.garg@sickkids.ca

    Indra Narang

Other trials in Canada

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
High Flow Nasal Cannula, Continuous Positive Airway Pressure
Keywords
obstructive sleep apnea, pediatric obstructive sleep apnea, children, adolescents, continuous positive airway pressure, CPAP, High Flow nasal cannula, HFNC, Sleep-disordered breathing, adherence, quality of life, home sleep therapy, randomized controlled trial
Medical subject headings
Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Flow Nasal CannulaDevice

    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.

  • Continuous Positive Airway PressureDevice

    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.

Study groups in NCT07600333
Study groupRoleWhat they receive
Continuous Positive Airway Pressure (CPAP)Active comparatorParticipants 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.
Receives: Device: Continuous Positive Airway Pressure
High-Flow Nasal Cannula (HFNC)ExperimentalParticipants 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.
Receives: Device: High Flow Nasal Cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (15)
  1. 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]

    Measured: Baseline and 3 months

  2. 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]

    Measured: Baseline and 3 months

  3. 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.

    Measured: Baseline and 3 months

  4. 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

    Measured: Baseline and 3 months

  5. 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.

    Measured: Baseline and 3 months

  6. 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.

    Measured: Baseline and 3 months

  7. 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.]

    Measured: Baseline and 3 months

  8. Perceived Comfort

    Perceived comfort of using CPAP or High-Flow Nasal Cannula therapy, measured using comfort questionnaires.

    Measured: 3 months

  9. 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.

    Measured: 3 months

  10. 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.]

    Measured: Baseline and 3 months

  11. 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.

    Measured: Baseline and 3 months

  12. 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.

    Measured: Baseline and 3 months

  13. 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

    Measured: Baseline and 3 months

  14. 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).

    Measured: Baseline and 3 months

  15. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completionNov 2031 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study uses a parallel-group, randomized controlled design conducted in real-world home settings. Eligible participants are randomly assigned in a 1:1 ratio to receive either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Cannula (HFNC) therapy and remain in their assigned group for the duration of the three-month intervention period. Outcomes are assessed using objective device data and validated questionnaires, with investigators blinded to the primary adherence outcome.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07600333
Sponsor's protocol ID
5447
Other IDs
198152
Acronym
CHOSA
Status last verified
May 2026
First submitted
7 May 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A study testing High Flow Nasal Cannula and Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea (OSA), run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aditi Garg ((416) 813 6809, aditi.garg@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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