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NCT Number: NCT05970562

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Boston Medical Center, Boston, Massachusetts, United States

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About this study

Vocal hyperfunction (VH) is ostensibly caused by and/or associated with pathological daily voice use and involves the most commonly treated voice disorders by speech-language pathologists, e.g., vocal fold nodules, muscle tension dysphonia. Voice therapy is the primary curative option for VH. For example, even when patients undergo laryngeal surgery to remove lesions, they are still thought to be at risk for recurrence unless they successfully complete post-surgical voice therapy. However, voice therapy suffers from high rates of patient dropout. Patients and clinicians report that generalizing desired vocal behaviors from the therapy session into daily life is one of the most significant barriers to successful voice therapy. Despite this critical barrier, voice therapy remains entirely dependent upon episodic delivery within an in-clinic or virtual session. Thus, this project will test if adding Ambulatory Voice Monitoring with Biofeedback (AVM-B) significantly addresses this generalization challenge, as it can directly extend therapeutic activities into the patient's daily life. A clinical trial will randomize patients with VH to receive an evidence-based therapy (Conversation Training Therapy; CTT) or CTT with AVM-B added. In Aim 1, it is hypothesized that, compared to patients who only received CTT, patients who receive CTT and AVM-B will demonstrate significantly better generalization during therapy which will be retained immediately after therapy and six months later. In Aim 2, we will explore patient factors that mediate the relationship between therapy and generalization, hypothesizing that stimulabilty-how easily a patient can modify their voice-and engagement-the patient's level of effort during therapy-will be positively correlated to the amount of generalization in daily life. If successful, this work would result in multiple paradigm-shifting impacts with potential to improve the efficiency of clinical practice. AVM-B would become one of the first evidence-based voice treatment activities taking place primarily outside the therapy session. Future work could investigate how AVM-B could transition voice therapy from once-a-week sessions into a continuous process integrated into the patient's daily life. Further inquiry could improve generalization by identifying evidence-based methods to tailor therapy based on individual patient factors such as stimulability and engagement. After discharge, AVM-B could provide a means for patients to "recalibrate" themselves and prevent relapse without having to see a clinician. Finally, implementation work could help clinicians adopt/adapt AVM-B and evaluate its effects on dropouts.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ambulatory Voice Monitoring with Biofeedback (AVM-B)

Device

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

Behavioral

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 outcomes

  1. Generalization

    Time frame: Before therapy, immediately after therapy, and 6 months after therapy

    Generalization will be represented as a "percent accuracy" where voiced frames of a feature that are above or below a percentile threshold (based on baseline/pre-therapy monitoring data) are divided by the total number of voiced frames.

  2. Stimulability

    Time frame: This will be calculated before therapy begins.

    Stimulability will be represented as a "percent accuracy" where voiced frames of a feature that are above or below a percentile threshold (based on baseline/pre-therapy monitoring data) are divided by the total number of voiced frames.

  3. Rehabilitation Treatment Intensity Scale (RITS)

    Time frame: Before therapy, immediately after therapy, and 6 months after therapy

    The RITS scale is one scale with 7 levels where the 1 represents the "absence of effort" and 7 represents "superior effort." The patient's treating clinician will judge his/her engagement during therapy after each session. These judgements will provide valid and reliable estimates of patient engagement.

  4. Consensus Auditory Perceptual Evaluation - Voice (CAPE-V)

    Time frame: Before therapy, immediately after therapy, and 6 months after therapy

    The CAPE-V consists of 4 perceptually judged 100-mm visual analog scales (Overall auditory perceptual severity, Breathiness, Strain, Roughness). The patient's treating clinician will judge standard audio samples. These judgements provide gold-standard perceptual ratings of voice quality to evaluate if therapy and AVM-B are associated with improved voice quality.

  5. Voice-Related Quality of Life (V-RQOL)

    Time frame: Before therapy, immediately after therapy, and 6 months after therapy

    The V-RQOL consists of 10 Likert-style questions ranging from 1-5 (1 = no problem at all; 2 = a small amount; 3 = a moderate problem; 4 = a lot; 5 = problem is as bas as it can be) that estimates how the subject's vocal function effects his/her daily life. This patient reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.

Study contacts

Contact information is provided by the study sponsor or research team.

Jarrad Van Stan, PhD, CCC-SLP

CONTACT

[email protected]

617-643-8410

Robert Hillman, PhD, CCC-SLP

CONTACT

617-643-2466

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston Medical Center
  • Emory University

Registry information

Official study title

Preliminary Studies to Test the Effects of Ambulatory Biofeedback in Small Groups of Patients With Vocal Hyperfunction: Study 3

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Aug 1, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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