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Can a simple valve help tracheostomy patients sleep better and safer?

NCT ID NCT06229639

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looked at whether it is safe for people with a tracheostomy (a breathing tube in the neck) to use a Passy Muir valve while sleeping. The valve helps them speak by redirecting air, but using it at night hasn't been well studied. Researchers monitored 33 patients in a long-term care hospital, checking heart rate, blood pressure, oxygen levels, and breathing. The goal was to see if nighttime use causes any breathing or heart problems.

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

33 people

The number who actually took part.

Started

Jan 2016

Finished

Feb 2018

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. Patient has evidence of respiratory insufficiency requiring a tracheostomy tube without current need for assisted ventilation. 2. Patient will be continuously monitored with telemetry. 3. Patient satisfies criteria for the decannulation protocol and agrees to use the Passy Muir Valve during sleep. 4. Patient is able to follow directions following speech/language/cognitive evaluation or screening completed by the Speech-Language Pathologist and physician assessment. 5. Patient is at least 18 years old. 6. An informed consent is signed by patient or Power of Attorney (POA). 7. Patient is able to tolerate the PMV during the day for a minimum of 6 continuous hours 8. Patient has a maximum size #6 Shiley cuffless tracheostomy tube or equivalent. Exclusion Criteria: 1. Patient identified at time of admission as requiring invasive long-term assisted ventilation. 2. Patient with documented or suspected upper airway obstruction and/or surgery or permanent tracheostomy tube. 3. Patient is quadriplegic (due to the inability for a quadriplegic patient to manually self-remove the valve in case of emergency). 4. Patient or POA failed to sign consent. 5. Pt has a severe cognitive impairment as determined by a formal cognitive-linguistic evaluation by a licensed Speech Language Pathologist. 6. Patient unable to meet criteria for decannulation protocol or has failed decannulation protocol within last two weeks.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

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

Tracheostomy

Contacts and locations

Locations

  • Gaylord Hospital

    Wallingford, Connecticut, 06492, United States

More trials for these conditions

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