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Tiny valve may help tracheostomy patients walk further

NCT ID NCT04941456

Symptom relief Sponsor: Gaylord Hospital, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether using a Passy-Muir valve (a small device that helps people with a tracheostomy speak) can also improve how far they can walk. 26 adults with a tracheostomy completed several 6-minute walk tests, alternating between using the valve and leaving the tracheostomy open. The goal was to see if the valve made walking easier and increased endurance.

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

26 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 2024

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: 1. Individual with tracheostomy who can tolerate daily 30 minute Physical Therapy sessions with use of PMV and be able to maintain oxygen saturations above 88% with exertion. 2. Ability to understand and respond to simple verbal instructions and one step commands in English well enough to consent without any interpretation. 3. Ability to ambulate a minimum of 10 feet with/without assistive device and with/without physical assistance. Exclusion Criteria: 1. Active seizures 2. Active Pregnancy 3. Uncontrolled hypertension 4. Cognitive deficits that would disrupt ability to provide informed consent 5. Enteric infection control precautions 6. Ongoing orthostasis 7. Actively on decannulation protocol 8. Medical instability that would cause a doctor to put therapy program on hold

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Conditions

The condition(s) this trial relates to.

MVP1

As listed by the trial registrant

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

Exercise endurance PMV Tracheostomy

Contacts and locations

Locations

  • Gaylord Hospital

    Wallingford, Connecticut, 06492, United States

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