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Simple mask could revolutionize sleep apnoea testing

NCT ID NCT06050720

Diagnosis Sponsor: University Hospitals of North Midlands NHS Trust 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This study tested a new, low-cost device called Apne-Scan to see if it can accurately detect sleep apnoea compared to standard home tests. Forty adults referred to a sleep clinic wore the Apne-Scan mask alongside their usual test overnight. The goal was to see if the simpler, cheaper device could reliably measure breathing pauses and help diagnose sleep apnoea.

What this could mean

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

Active substance
Apne-Scan DC1 device (a mask with a pressure sensor)
What this could lead to
If it works, this could provide a cheaper, simpler way to screen for sleep apnoea at home, making testing more accessible.
What could go wrong
This is a small, early exploratory study with only 40 participants. The new device may not match the accuracy of standard tests, and results may not apply to everyone.

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

40 people

The number who actually took part.

Started

Mar 2024

Finished

Nov 2025

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

18 to 75 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: * Have been referred by a clinician to the sleep clinic for diagnosis of a sleep disorder, possibly sleep apnoea. * Be about to be screened for possible sleep apnoea using a standard sleep apnoea test device. * Be between the ages of 18 and 75 and have provided informed consent for the study Exclusion Criteria: * Have not been referred by a clinician to a sleep clinic for diagnostic tests for sleep disorders other than for possible sleep apnoea. * Cannot tolerate wearing a mask overnight. * Cannot remove a mask should they become distressed. * Are not capable of understanding the English language version of Apne-Scan's Instructions For Use (IFU). * Are under the age of 18 years old or over the age of 75 years old. * Are not capable of giving informed consent

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Conditions

The condition(s) this trial relates to.

sleep apnea syndrome

As listed by the trial registrant

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

Sleep apnea

Contacts and locations

Locations

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, United Kingdom

More trials for these conditions

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