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Could a Head-Worn CPAP device make sleep apnea treatment easier?

NCT ID NCT07785310

Symptom relief Sponsor: ResMed 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests a new, compact CPAP device worn on the head, designed to treat obstructive sleep apnea. Ten adults who already use CPAP will try the device during a supervised daytime nap to see how comfortable, stable, and easy it is to use. The goal is to gather feedback that could help refine this wearable technology for future sleep apnea treatment.

What this could mean

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

Active substance
A prototype wearable positive airway pressure (PAP) device, a compact head-worn CPAP system for obstructive sleep apnea.
What this could lead to
If successful, this could lead to a more comfortable, portable CPAP alternative that may improve adherence and quality of life for people with sleep apnea.
What could go wrong
This is a very small early-stage pilot study focused on short-term comfort, not long-term effectiveness. The device may not be practical or well-tolerated in real-world use.

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 10 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Willing and able to provide written informed consent * Able to read and comprehend English * Aged 18 years or older * Currently using continuous positive airway pressure (CPAP) therapy for at least 3 months for treatment of obstructive sleep apnea (OSA) * Using CPAP mode with a fixed therapeutic pressure less than 16 cmH2O * Current user of a nasal mask interface and appropriately fitted to a medium-sized nasal mask * Agree to supervised monitoring, including video observation, during the nap session * Willing and able to attend a single in-clinic visit and attempt a supervised daytime nap of up to 90 minutes using the investigational device Exclusion Criteria: * Current use of bilevel positive airway pressure devices * Pregnant or possibly pregnant * Pre-existing lung disease or condition that may predispose to pneumothorax (e.g., chronic obstructive pulmonary disease \[COPD\], lung cancer, pulmonary fibrosis, recent pneumonia or lung infection within the past 2 years, or lung injury) * Active implanted medical devices that may interact with magnets, including pacemakers, implantable cardioverter defibrillators (ICDs), neurostimulators, cerebrospinal fluid shunts, or infusion pumps * Any condition or circumstance that, in the opinion of the investigator, could make participation unsafe or interfere with interpretation of study results * Currently enrolled in another clinical study

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

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

Obstructive sleep apnea

How to take part

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  1. 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 ↗

  2. A doctor treating you

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