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New TrachPhone device could make breathing easier for tracheostomy patients

NCT ID NCT06487104

Symptom relief Sponsor: Atos Medical AB 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This study compares a new device called TrachPhone, which adds moisture to the air people breathe through a tracheostomy tube, to a standard humidifier. The goal is to see if TrachPhone helps manage lung secretions better and is safe and easy to use. The trial involves 22 adults with a tracheostomy due to a neurological condition who are not in intensive care.

What this could mean

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

Active substance
TrachPhone HME device
What this could lead to
If it works, this could offer a more convenient and effective way to manage lung secretions for people with a tracheostomy.
What could go wrong
This is a small, early-stage study with only 22 participants, so results may not apply to everyone. The device may not improve secretion management or could cause discomfort.

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 22 people

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

Started

Feb 2025

Expected to finish

Dec 2026

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: * Tracheostomy patient outside critical care * Self-ventilating via a tracheostomy tube, independent of cuff status * 18 years or older Exclusion Criteria: * Patients with tidal volume beyond recommended range (50-1000 ml) * Dehydration * Very heavy/excessive secretion from the lungs and airways (requiring more frequently tracheal suction, more than hourly suctioning) * High oxygen need (FiO2 \> 0.4) * Acutely deteriorating patient

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As listed by the trial registrant

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

Tracheostomy

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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 Royal London Hospital, Barts Health NHS Trust

    London, United Kingdom

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