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Talking valve trial aims to help tracheostomy patients speak and breathe easier

NCT ID NCT07422350

Symptom relief Sponsor: Jingyi Ge 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether using a speaking valve can improve breathing and other health measures in people with a tracheostomy. Researchers will use wearable devices to track 120 adults' breathing rate, heart rate, and oxygen levels while they use the valve for 30 minutes. The goal is to find out who can tolerate the valve and help more patients successfully remove their tracheostomy tube.

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.

Participants

About 120 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 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.

Who is studied

Population:Tracheostomy patients in a rehabilitation hospital undergoing pre-decannulation rehabilitation

Ages

18 to 90 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: 1. Patient is not receiving mechanical ventilation. 2. Tolerates cuff deflation. 3. Upper airway patency is good, TTP \< 10 cmH2O. 4. Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled. 5. PaCO2\<60 mmHg. Exclusion Criteria: 1. Cannot tolerate deflation balloon. 2. Severe upper airway obstruction 3. Unstable vital signs. 4. Thick secretions, compromised airway protection. 5. PaCO2 ≥60 mmHg.

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As listed by the trial registrant

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

Tracheostomy decannulation

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

    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

  • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

    Beijing, Beijing Municipality, 100043, China

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