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Could a simple breathing device help children speak more clearly without surgery?

NCT ID NCT05492266

Disease control Sponsor: Noel Jabbour Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests whether a handheld device that strengthens the muscles used for breathing and swallowing can improve speech in children aged 5 to 17 with velopharyngeal dysfunction, a condition where the soft palate does not close properly, causing nasal-sounding speech. Participants are randomly assigned to use the device daily for 6 to 8 weeks or to receive no exercises. The goal is to see if this non-surgical approach can reduce hypernasality and improve quality of life.

What this could mean

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

Active substance
a handheld breathing exercise device called EMST-150
What this could lead to
If effective, this simple exercise device could provide a non-surgical way to improve speech in children with velopharyngeal dysfunction.
What could go wrong
This is a small, early-stage trial with only 30 participants. The exercises may not improve speech for everyone, and results may not apply to all patients.

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 30 people

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

Started

Mar 2025

Expected to finish

Nov 2027

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

5 to 17 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: * Score of 2 or greater on the nasality/resonance domain of the Pittsburgh Weighted Speech Scale * Ages 5-17 years Exclusion Criteria: * CAPS-A-AM hypernasality score \<2 * Previous speech surgery (e.g. palatoplasty or pharyngeal flap for speech) * Speech surgery scheduled within the next 56 days * Unable or unwilling to perform the tests and exercises outlined in the study

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Conditions

The condition(s) this trial relates to.

cleft palate congenital velopharyngeal incompetence Speech Intelligibility

As listed by the trial registrant

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

Hypernasality Inadequate velopharyngeal closure Palatopharyngeal incompetence Velopharyngeal incompetence due to cleft palate Velopharyngeal insufficiency

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

  • UPMC Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

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