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Wearable biofeedback could help voice therapy stick in daily life

NCT ID NCT05970562

Disease control Sponsor: Massachusetts General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study tests whether a wearable device that gives real-time feedback on voice use can help people with voice disorders (like vocal nodules or muscle tension dysphonia) improve their voicing habits outside the clinic. Participants wear a small sensor on their neck that tracks vibrations during speech and provides cues when they exceed a personalized threshold. The study combines this device with a 4-week voice therapy program to see if it helps patients generalize healthier voicing into everyday conversations.

What this could mean

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

Active substance
a wearable device that monitors voice and gives biofeedback (ambulatory voice monitoring with biofeedback, AVM-B) plus conversation training therapy
What this could lead to
If it works, this approach could make voice therapy more effective by helping patients use healthier voicing habits in their everyday lives, not just in the clinic.
What could go wrong
This is an early, small study. The device may be distracting or uncomfortable, and the benefits might not be large enough to justify its use in routine therapy.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 100 people

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

Started

Mar 2024

Expected to finish

Apr 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 to 65 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 for PVH: * Diagnosis of vocal fold nodules and polyps. * Secondary diagnosis of laryngopharyngeal reflux (LPR) or gastro-esophageal reflux disease (GERD) * Secondary diagnoses commonly associated with phonotrauma like erythema, edema, varies, ectasia, laryngitis, secondary/reactive muscle tension dysphonia (MTD), hemorrhage, etc. Exclusion criteria for PVH: * Any secondary diagnosis not directly related to phonotrauma, like cyst, sulk, cancer, bamboo nodule, known or suspected paralysis, etc. Inclusion criteria for NPVH: * Diagnosis of primary MTD. * Allowable secondary diagnoses are LPR and GERD. Exclusion criteria for NPVH: * Any secondary diagnosis related to pathological structure (e.g., nodules, polyps, edema, cancer), neurology (e.g., paralysis, Parkinson's Disease), or respiration (e.g., chronic cough, paradoxical vocal fold motion).

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Conditions

The condition(s) this trial relates to.

polyp of vocal cord spasmodic dystonia voice disorders

As listed by the trial registrant

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

Muscle tension dysphonia Vocal fold polyp Vocal nodules in adults Voice disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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