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Can a smart breathing device make life with a tracheostomy more comfortable?

NCT ID NCT07798414

Symptom relief Sponsor: University of South Florida 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether the TrachPhone, a device that adds heat and moisture to the air you breathe, can improve comfort and lung recovery in people who have a tracheostomy after head and neck cancer surgery. Half of the 80 participants will use the TrachPhone, while the other half will receive standard care with a trach collar. Researchers will measure patient satisfaction using a questionnaire and track lung function during the hospital stay.

What this could mean

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

Active substance
TrachPhone Heat Moisture Exchanger (HME), a device that adds heat and moisture to breathed air, with a speaking valve and ports for oxygen and suctioning
What this could lead to
If it works, the TrachPhone could become a standard option for people with a tracheostomy after head and neck cancer surgery, making breathing more comfortable and supporting lung recovery.
What could go wrong
This is an early-stage trial with only 80 participants, so the results may not apply to everyone. The device may not improve satisfaction or lung function enough to justify its use, and some patients may find it difficult to put on or take off.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 80 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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

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: * Patients over 18 years old with diagnosis of head and neck cancer who received a tracheostomy after their surgery in the acute care setting. Exclusion Criteria: * Patients with head and neck cancer who did not receive a tracheostomy in the post-operative period. * Patients with tracheostomy on mechanical ventilation in the post-operative period. * Patients who are unable to don on/off the TrachPhone HME. * Patients who has a cuffed tracheostomy.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms Patient Satisfaction

As listed by the trial registrant

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

Patient satisfaction Pulmonary rehabilitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  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

  • Tampa General Hospital

    Tampa, Florida, 33626, United States

  • University of South Florida

    Tampa, Florida, 33626, United States

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