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New wearable device aims to track infant breathing pauses during sleep

NCT ID NCT06093347

Diagnosis 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 planned to test a new wearable wireless device that wraps around a child's abdomen to monitor central sleep apnea. It would have involved 15 children aged 1 month to 5 years already undergoing standard sleep studies. The device's accuracy and comfort would have been compared to existing hospital sensors. However, the study was withdrawn before any participants were enrolled.

What this could mean

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

Active substance
wearable wireless central apnoea monitor
What this could lead to
If successful, this device could offer a simpler, less intrusive way to monitor breathing pauses during sleep in young children.
What could go wrong
This was a very small feasibility study (only 15 children) and it was withdrawn before any participants were enrolled, so no results are available. The device may not prove accurate or acceptable in practice.

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.

Started

Sep 2023

Finished

Mar 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.

Who is studied

Children admitted to the Sleep Unit at Sheffield Children's Hospital with suspected sleep apnoea

Ages

1 month to 5 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 who have been referred for a cardio-respiratory polygraphy sleep study. * Patients aged 1 month up to 5 years old. Exclusion Criteria: * Subjects whose parents/legal guardians/carers are not fluent in English, or who have special communication needs. * Child anticipated to become distressed with additional sensor. * Child too clinically unwell to take part (as decided by clinical staff).

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Conditions

The condition(s) this trial relates to.

central sleep apnea syndrome 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

  • Clinical Research Facility, Sheffield Children's Hospital

    Sheffield, United Kingdom

More trials for these conditions

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