RecruitingEarly Phase 1

Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction

United States100 participantsStarted 2024-03-01

Plain-language summary

Vocal hyperfunction (VH) is the most commonly treated class of voice disorders by speech-language pathologists and voice therapy is the primary curative treatment. Patients and clinicians report that generalizing improved voicing into daily life is the most significant barrier to successful therapy. We will test if extending biofeedback into the patient's daily life using ambulatory voice monitoring will significantly improve generalization during therapy and if individual patient factors, like how easily they can modify their voice and engagement during therapy, moderate the effects of the biofeedback.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Generalization

Timeframe: Before therapy, immediately after therapy, and 6 months after therapy

Stimulability

Timeframe: This will be calculated before therapy begins.

Rehabilitation Treatment Intensity Scale (RITS)

Timeframe: Before therapy, immediately after therapy, and 6 months after therapy

Consensus Auditory Perceptual Evaluation - Voice (CAPE-V)

Timeframe: Before therapy, immediately after therapy, and 6 months after therapy

Voice-Related Quality of Life (V-RQOL)

Timeframe: Before therapy, immediately after therapy, and 6 months after therapy

Trial details

NCT IDNCT05970562

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Jarrad Van Stan, PhD, CCC-SLP

617-643-8410 jvanstan@mgh.harvard.edu

View on ClinicalTrials.gov More Voice Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Generalization

Timeframe: Before therapy, immediately after therapy, and 6 months after therapy

Stimulability

Timeframe: This will be calculated before therapy begins.

Rehabilitation Treatment Intensity Scale (RITS)

Timeframe: Before therapy, immediately after therapy, and 6 months after therapy

Consensus Auditory Perceptual Evaluation - Voice (CAPE-V)

Timeframe: Before therapy, immediately after therapy, and 6 months after therapy

Voice-Related Quality of Life (V-RQOL)

Timeframe: Before therapy, immediately after therapy, and 6 months after therapy