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Could a gentler nasal tube replace the CPAP mask for kids with sleep apnea?

NCT ID NCT07600333

Disease control Sponsor: The Hospital for Sick Children Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a high-flow nasal cannula (HFNC) — a soft tube that delivers warm, humidified air through the nose — works as well as the standard CPAP mask for children with moderate-to-severe obstructive sleep apnea. About 258 children aged 2 to 18 will use one of the two devices nightly for 3 months. Researchers will measure how often each device is used, how it affects sleep symptoms and quality of life, and how comfortable it feels. The goal is to find a treatment that kids can tolerate better without losing effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-Flow Nasal Cannula (HFNC) and Continuous Positive Airway Pressure (CPAP) devices
What this could lead to
If HFNC works as well as CPAP but is more comfortable, it could give children with sleep apnea a better-tolerated treatment option, improving their sleep and quality of life.
What could go wrong
This is an early-stage comparison study, not yet recruiting. HFNC may not be as effective as CPAP, and children might still struggle with adherence. Results may not apply to all ages or severities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea (OSA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Hospital for Sick Children

    Toronto, Ontario, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.