CPAP vs High-Flow Nasal Cannula for Sleep Apnea

(CHOSA Trial)

AG
Overseen ByAditi Garg
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for obstructive sleep apnea (OSA) in children. OSA causes breathing to stop and start during sleep, impacting health and daily life. The study compares Continuous Positive Airway Pressure (CPAP), which uses a mask to deliver air and keep airways open, with High-Flow Nasal Cannula (HFNC), which uses soft prongs to deliver warm air and may offer more comfort. Children with moderate-to-severe OSA who struggle with CPAP at night may be suitable candidates for this trial. The researchers aim to determine if HFNC can serve as a comfortable and effective alternative to CPAP. As an unphased trial, this study provides a unique opportunity for children to explore potentially more comfortable treatment options.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both CPAP and HFNC treatments are generally safe for children with obstructive sleep apnea (OSA). CPAP, used for many years, is effective but can be uncomfortable for some children.

Studies have found that HFNC improves sleep apnea symptoms by reducing the frequency of breathing interruptions during sleep. HFNC delivers warm, moist air through soft nasal prongs, which many find more comfortable than CPAP masks. However, children might not use HFNC as consistently as CPAP.

No major side effects have been reported for either treatment. Both are non-invasive and help keep the airway open during sleep. Overall, both treatments are well-tolerated and aim to improve sleep quality and comfort for children with OSA.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for sleep apnea because they offer alternative ways to keep airways open during sleep. Continuous Positive Airway Pressure (CPAP) is a well-known method that uses a mask to deliver pressurized air, effectively preventing airway collapse. The High-Flow Nasal Cannula (HFNC) is different because it delivers warmed, humidified air at high flow rates through soft nasal prongs, which might be more comfortable and easier to tolerate for some patients. This trial aims to see if HFNC can be as effective as CPAP, potentially providing a more patient-friendly treatment option for obstructive sleep apnea.

What evidence suggests that this trial's treatments could be effective for obstructive sleep apnea?

This trial will compare Continuous Positive Airway Pressure (CPAP) with High-Flow Nasal Cannula (HFNC) for treating obstructive sleep apnea (OSA). Research has shown that CPAP helps treat OSA by keeping the airway open during sleep, with many children experiencing symptom improvement, although some find it uncomfortable.

Participants in this trial may receive HFNC, which studies suggest could be a good alternative to CPAP, especially for children. HFNC delivers warm, moist air through small tubes in the nose, potentially offering more comfort and ease of use for kids. Research indicates that HFNC can reduce OSA symptoms, though it might not be as effective as CPAP. However, its comfort and ease of use could make it a suitable option for those who have trouble with CPAP.12356

Who Is on the Research Team?

IN

Indra Narang

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for children aged 2 to 18 years who have moderate-to-severe obstructive sleep apnea and are not able to be treated with surgery.

Inclusion Criteria

I have moderate to severe obstructive sleep apnea confirmed by a recent sleep study.
I am between 2 and 18 years old.
I need to use CPAP therapy for my condition.
See 1 more

Exclusion Criteria

I need a breathing machine that controls my breaths due to low breathing.
I have central sleep apnea with at least 5 events per hour.
I have used CPAP or high-flow nasal cannula for sleep apnea in the past year.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to use either CPAP or HFNC at home during sleep for 3 months

12 weeks
Device setup and optimization visits

Follow-up

Participants are monitored for adherence, sleep-related symptoms, and quality of life after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Positive Airway Pressure (CPAP)
  • High Flow Nasal Cannula (HFNC)

Trial Overview

The study compares two home treatments for sleep apnea in children: CPAP, which uses a mask to deliver pressurized air, and High-Flow Nasal Cannula (HFNC), which delivers warm, humidified air through soft nasal prongs. Children are randomly assigned to use one of these treatments during sleep for 3 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: High-Flow Nasal Cannula (HFNC)Experimental Treatment1 Intervention
Group II: Continuous Positive Airway Pressure (CPAP)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Fisher and Paykel Healthcare

Industry Sponsor

Trials
127
Recruited
11,000+
Dr. Justin Vaughan profile image

Dr. Justin Vaughan

Fisher and Paykel Healthcare

Chief Medical Officer since 2024

MD from the University of Auckland

Lewis Gradon profile image

Lewis Gradon

Fisher and Paykel Healthcare

Chief Executive Officer since 2016

Bachelor of Science in Physics from the University of Auckland, New Zealand

Citations

Effect of high-flow nasal cannula therapy on adults with ... - PMC

Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder. There has been some evidence that patients with OSA may benefit ...

High Flow Nasal Cannula for Obstructive Sleep Apnea

The ODI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure. 2 days. Secondary Outcome Measures ...

Efficacy of high-flow nasal cannula therapy and its ...

HFNC is an alternative treatment option with comparable efficacy to CPAP in alleviating disease severity in paediatric patients with MS-OSA.

Effect of high-flow nasal cannula therapy on adults with...

The pooled analysis revealed that HFNC therapy led to a significant reduction in apnea–hypopnea index (mean difference [MD] = −8.90; 95% ...

CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea ...

The results are expected to clarify whether HFNC offers a more acceptable or effective alternative for children who struggle with standard CPAP ...

High-Flow Nasal Oxygen Improves Safe Apnea Time in ...

Results: The HFNO group demonstrated a significantly prolonged safe apnea time compared to the Control group (18.1 [12.1,18.8] vs 4.2 [2.5,6.3] ...