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Tongue training device aims to restore speech after cancer surgery

NCT ID NCT07110142

Symptom relief Sponsor: Case Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests whether starting tongue strengthening exercises early, using a device called the Tongueometer, can improve speech and swallowing in people who have had part of their tongue removed due to cancer. The device uses a small air-filled bulb and a mobile app to guide exercises and track progress. Researchers hope this proactive approach leads to better quality of life than waiting to treat problems after they arise. The trial will enroll 40 adults undergoing partial or hemiglossectomy with reconstruction.

What this could mean

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

Active substance
Tongueometer device (biofeedback tongue strengthening exercise program)
What this could lead to
If it works, this could establish a new standard of care to help people speak and swallow better after tongue cancer surgery.
What could go wrong
This is a small, early-stage study with only 40 participants, so results may not apply to everyone. The exercises may not lead to meaningful improvements over standard care.

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 40 people

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

Started

Dec 2025

Expected to finish

Jun 2029

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: 1. ≥18 years of age 2. No prior history of head and neck cancer 3. No prior history of radiation 4. Planned to undergo resection of ≤50% of the native tongue (partial/hemiglossectomy) with immediate reconstruction, including free flap reconstruction, and with or without neck dissection 5. Sufficiently fluent in written English, French, Spanish or Simplified Chinese to complete the study outcomes questionnaires Exclusion Criteria: 1. Distant metastasis at enrollment 2. Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes 3. Prior head and neck radiation 4. Requires mandibulectomy or \>50% resection of native tongue

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms lip and oral cavity carcinoma Mouth Neoplasms tongue cancer

As listed by the trial registrant

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

Head and neck cancer Oral cancer

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

  • Case Comprehensive Cancer Center, Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

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