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

NCT07600333 | Not Yet Recruiting DMC

• 2 other identifiers: 5447198152
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnea (OSA)

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

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (15)

• 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

Other Outcomes (1)

• Participant and Caregiver Experience With Therapy

  at end of intervention of 3 month

Study Arms (2)

Continuous Positive Airway Pressure (CPAP)

ACTIVE COMPARATOR

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

High-Flow Nasal Cannula (HFNC)

EXPERIMENTAL

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

Interventions

High Flow Nasal Cannula DEVICE

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.

High-Flow Nasal Cannula (HFNC)

Continuous Positive Airway Pressure DEVICE

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.

Continuous Positive Airway Pressure (CPAP)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Indra Narang

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aditi Garg

CONTACT

(416) 813 6809; aditi.garg@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP, Health Equity and Inclusion

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

CA (1)