Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Custom 3D-printed masks aim to give kids with breathing problems a better night's sleep

NCT ID NCT07391150

Symptom relief Sponsor: Sheffield Children's NHS Foundation 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests custom-made 3D-printed masks for children who use a breathing machine (NIV) at night. Many kids struggle with standard masks that leak, cause sores, or don't fit properly. The new masks are designed from a 3D scan of each child's face to improve comfort and fit. About 195 children aged 1 month to 16 years will try the custom mask and compare it to their current one.

What this could mean

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

Active substance
custom 3D-printed NIV mask and headgear
What this could lead to
If it works, this could provide a comfortable, well-fitting mask for children who currently have no good options, reducing pressure sores and sleep disruption.
What could go wrong
This is a small pilot study, not a large trial. The custom masks may not fit better than standard ones, and the manufacturing process needs further development.

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 195 people

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

Started

Feb 2024

Expected to finish

Mar 2026

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

1 month to 16 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: * Patients requiring NIV as part of usual clinical care at SCH * Age 1 month to 16 years. * Difficulties with current NIV interface * Only patients that are using NIV for breathing support will be included, ie those with hypoventilation and obstructive sleep apnoea, where the ventilator supports the patient's own breathing. Exclusion Criteria: * Families who do not understand written or verbal English where no interpreter is available. * Children who do not attend with their parent /legal guardian and so are therefore unable to give informed consent. * Patients deemed too unwell, or unsuitable, by the clinical team * Patients with adequately functioning NIV interface. * Patients requiring supplementary medical gases, eg oxygen. * Patients requiring NIV for rescue breaths will be excluded, ie those with disorders of respiratory control where the ventilator is delivering breaths where the patient has stopped breathing.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Respiratory insufficiency are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

respiratory failure

As listed by the trial registrant

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

Respiratory insufficiency

Contacts and locations

Locations

  • Sheffield Children's Hospital, Sheffield, UK

    Sheffield, S6 5AW, United Kingdom

More trials for these conditions

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