Recruiting
Early Phase 1

Biofeedback & Voice Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT05970562

Conditions

Voice Disorders

Vocal Fold Polyp

Vocal Nodules in Adults

Muscle Tension Dysphonia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ambulatory Voice Monitoring with Biofeedback (AVM-B)

Conversation Training Therapy

Study Details

Brief 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.

Conditions

Voice Disorders

Vocal Fold Polyp

Vocal Nodules in Adults

Muscle Tension Dysphonia

Study ID

NCT05970562

Start date

Mar 1, 2024

Status verified date

Sep, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Conversation Training Therapy with Ambulatory Voice Biofeedback

Conversation Training Therapy will be administered one time per week for 1 hour. Ambulatory Voice Monitoring with Biofeedback will be administered during the second therapy session and for 5 days between the second and third therapy sessions.

active comparator: Conversation Training Therapy alone

Conversation Training Therapy will be administered one time per week for 1 hour.

Interventions

Ambulatory Voice Monitoring with Biofeedback (AVM-B)

AVM-B is software on the Voice Health Monitor that uses a neck-placed accelerometer to sense neck skin vibrations during voicing in daily life. The AVM-B consists of cues every time the patient exceeds a subject-specific threshold, \[100% frequency AVM-B\] and/or summary statistics every 2 minutes of voicing \[Summary AVM-B\].

Conversation Training Therapy

CTT is a 4-week (1 45-minute session per week) evidence-based voice therapy for patients with VH, developed primarily to maximize the amount and speed of generalization outside the therapy session. It consists of 3 required targets: Decreased overall auditory-perceptual voice severity, improved discrimination between baseline and improved voicing, and adherence to CTT recommendations in daily life. The three optional targets are decreased overall auditory-perceptual severity across an increased pitch range, loudness range, and decreased rate of speech. All voice-related targets are modified through practicing voicing with increased forward resonance and mean airflow in spontaneous speech/conversation.

Primary outcome measure

  • Generalization [ Time Frame: Before therapy, immediately after therapy, and 6 months after therapy ]
  • Stimulability [ Time Frame: This will be calculated before therapy begins. ]
  • Rehabilitation Treatment Intensity Scale (RITS) [ Time Frame: Before therapy, immediately after therapy, and 6 months after therapy ]
  • Consensus Auditory Perceptual Evaluation - Voice (CAPE-V) [ Time Frame: Before therapy, immediately after therapy, and 6 months after therapy ]
  • Voice-Related Quality of Life (V-RQOL) [ Time Frame: Before therapy, immediately after therapy, and 6 months after therapy ]

Central Contacts and Locations

Central contacts

Jarrad Van Stan, PhD, CCC-SLP

216-687-3883j.vanstan82@csuohio.edu

Robert Hillman, PhD, CCC-SLP

617-643-2466

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Robert Hillman, PhD, CCC-SLP

617-643-2466HILLMAN.ROBERT@MGH.HARVARD.EDU

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Lauren Tracy, MD

617-638-8124Lauren.Tracy@bmc.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-08.