Biofeedback and Voice Therapy for Voice Disorders

Recruiting at 1 trial location

Overseen By Robert Hillman, PhD, CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Massachusetts General Hospital

Disqualifiers: Cancer, Paralysis, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special voice therapy with biofeedback for individuals with voice disorders such as vocal nodules or muscle tension dysphonia. Biofeedback uses technology to provide real-time feedback, aiding patients in applying therapy lessons to daily life. The trial will compare regular therapy with therapy that includes biofeedback, known as Ambulatory Voice Monitoring with Biofeedback (AVM-B), to determine its effectiveness. Individuals experiencing voice issues like nodules or muscle tension dysphonia, often associated with conditions like acid reflux, might be suitable candidates. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to experience this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Ambulatory Voice Monitoring with Biofeedback is safe for treating voice disorders?

Research has shown that ambulatory voice monitoring with biofeedback (AVM-B) is generally safe for people with voice issues. Studies involving both healthy individuals and those with voice disorders have not identified any safety problems. While AVM-B remains under investigation, no harmful effects have been reported so far.

The current trial is in an early stage, focusing primarily on safety and potential effectiveness. For those considering participation, it is reassuring that previous studies have found this treatment to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they introduce a fresh approach to managing voice disorders. Unlike traditional treatments that often focus solely on structured voice exercises, these therapies incorporate real-time feedback and natural conversation practice. The use of Ambulatory Voice Monitoring with Biofeedback (AVM-B) is particularly notable as it provides patients with immediate, actionable insights into their vocal habits during everyday situations. This combination promises a more dynamic and personalized therapy experience, potentially leading to more effective and lasting improvements in voice quality.

What evidence suggests that Ambulatory Voice Monitoring with Biofeedback is effective for vocal hyperfunction?

Research has shown that Ambulatory Voice Monitoring with Biofeedback (AVM-B), which participants in this trial may receive, can enhance voice therapy outcomes for individuals with vocal hyperfunction. One study found that participants using this method spoke more softly, reducing their vocal loudness by an average of 4.4 decibels. They also adhered to therapy instructions 16.8% more often in their daily lives. This suggests that AVM-B might help individuals apply the benefits of voice therapy to everyday activities, thereby making their treatment more effective. ^{1 2 4 5 6}

Who Is on the Research Team?

Jarrad Van Stan, PhD, CCC-SLP

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with voice disorders such as Vocal Nodules, Polyps, or Muscle Tension Voice Disorder. Participants must have a diagnosis of vocal fold nodules or polyps and may also have related conditions like reflux diseases. It's not suitable for those who don't meet these specific criteria.

Inclusion Criteria

I have been diagnosed with nodules or polyps on my vocal cords.

I have voice issues due to vocal cord damage.

I have been diagnosed with reflux disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Conversation Training Therapy (CTT) once a week for 1 hour. Ambulatory Voice Monitoring with Biofeedback (AVM-B) is added during the second session and continues for 5 days between the second and third sessions.

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments immediately after therapy and 6 months later.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ambulatory Voice Monitoring with Biofeedback (AVM-B)

Trial Overview The study tests if using Ambulatory Voice Monitoring with Biofeedback (AVM-B) alongside Conversation Training Therapy helps patients integrate better voicing into daily life. The impact of patient factors on the effectiveness of biofeedback will also be examined.

How Is the Trial Designed?

Group I: Conversation Training Therapy with Ambulatory Voice Biofeedback Experimental Treatment 2 Interventions

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.

Group II: Conversation Training Therapy alone Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Published Research Related to This Trial

Biofeedback therapy shows promise in improving voice quality for various phonatory disorders, with 16.7% of studies indicating it was ineffective compared to other therapies, suggesting a generally positive trend in efficacy.

The review highlights a lack of randomized controlled trials, indicating a need for better research methodologies, including the use of acoustic voice quality parameters to assess the effectiveness of biofeedback in voice treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of biofeedback in phonatory disorders and phonatory performance: a systematic literature review. Maryn, Y., De Bodt, M., Van Cauwenberge, P.[2018]

In a proof-of-concept study with six participants, ambulatory biofeedback significantly reduced daily vocal intensity by an average of 4.4 dB and increased compliance by 16.8 percentage points during the feedback period.

However, the changes in vocal intensity and compliance did not persist after the biofeedback was removed, indicating that while biofeedback can modify vocal behavior, it may not lead to lasting changes without continued support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Voice Ambulatory Biofeedback on the Daily Performance and Retention of a Modified Vocal Motor Behavior in Participants With Normal Voices. Van Stan, JH., Mehta, DD., Hillman, RE.[2022]

A miniature accelerometer placed on the neck can effectively collect data on vocal behaviors in patients with hyperfunctional voice disorders, allowing for monitoring during daily activities.

Preliminary results suggest that this ambulatory voice monitoring could enhance the diagnosis and treatment of these disorders by differentiating between hyperfunctional and normal vocal patterns using various analytical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Ambulatory Voice Monitoring to Investigate Common Voice Disorders: Research Update. Mehta, DD., Van Stan, JH., Zañartu, M., et al.[2022]

In a study involving 17 female patients with phonotraumatic vocal hyperfunction, all three variations of voice ambulatory biofeedback (VAB) led to improved adherence to desired vocal intensity levels, indicating its efficacy in promoting better voice use.

The improvements in vocal performance were maintained for up to one week after the biofeedback was removed, suggesting that VAB can effectively support long-term retention of therapeutic voice use in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory Voice Biofeedback: Acquisition and Retention of Modified Daily Voice Use in Patients With Phonotraumatic Vocal Hyperfunction. Van Stan, JH., Ortiz, AJ., Sternad, D., et al.[2022]

The study involved 48 nurses using the Voice Health Monitor over 6 days, which showed that all participants significantly improved their ability to speak softer during biofeedback days compared to baseline, indicating the effectiveness of ambulatory voice biofeedback.

The group receiving summary feedback maintained their improved vocal behavior better during both short-term and long-term retention days compared to those receiving continuous feedback, suggesting that less frequent feedback may enhance retention of desired voice behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory Voice Biofeedback: Relative Frequency and Summary Feedback Effects on Performance and Retention of Reduced Vocal Intensity in the Daily Lives of Participants With Normal Voices. Van Stan, JH., Mehta, DD., Sternad, D., et al.[2022]

Vocal therapy significantly improved vocal quality and muscle electrical activity in women with behavioral dysphonia, as shown in a randomized trial with 22 participants over eight sessions.

The addition of electromyographic biofeedback enhanced muscle electrical activity during phonation more than traditional vocal therapy alone, suggesting it may provide longer-lasting benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Voice Therapy Associated With Electromyographic Biofeedback in Women With Behavioral Dysphonia: Randomized Placebo-Controlled Double-Blind Clinical Trial. Ribeiro, VV., Gabriela de Oliveira, A., da Silva Vitor, J., et al.[2019]

Ambulatory voice biofeedback (AVB) can enhance voice therapy by helping patients maintain desired vocal behaviors outside of therapy sessions, with new settings allowing for adjustable feedback frequency and summary statistics.

A clinical case study showed that reduced-frequency AVB improved the carryover of therapeutic vocal behavior, such as reduced vocal intensity, suggesting that manipulating feedback schedules may enhance the effectiveness of voice therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of Motor Learning Principles Into Real-Time Ambulatory Voice Biofeedback and Example Implementation Via a Clinical Case Study With Vocal Fold Nodules. Van Stan, JH., Mehta, DD., Petit, RJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05970562?cond=%22Voice%20Disorders%22&aggFilters=status:not%20rec&rank=8

Project 4: Ambulatory Biofeedback and Voice Therapy for ... We will test if extending biofeedback into the patient's daily life using ambulatory voice monitoring will significantly improve generalization during therapy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5548081/

Ambulatory Voice Biofeedback: Relative Frequency and ... Ambulatory voice biofeedback has the potential to significantly improve voice therapy effectiveness by targeting carryover of desired behaviors outside the ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2015_JSLHR-S-14-0159

The Effect of Voice Ambulatory Biofeedback on the Daily ... Compared to baseline days, participants exhibited a statistically significant decrease in mean vocal intensity (4.4 dB) and an increase in compliance (16.8 ...

4. withpower.com withpower.com/trial/early-phase-1-dysphonia-8-2024-93191

Biofeedback and Voice Therapy for Voice Disorders In a proof-of-concept study with six participants, ambulatory biofeedback significantly reduced daily vocal intensity by an average of 4.4 dB and increased ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4607864/

Using Ambulatory Voice Monitoring to Investigate Common ... Preliminary results demonstrate the potential for ambulatory voice monitoring to improve the diagnosis and treatment of common hyperfunctional voice disorders.

6. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2016_JSLHR-S-16-0164

Ambulatory Voice Biofeedback: Relative Frequency and ... This study applies motor learning concepts (reduced frequency and delayed, summary feedback) that demonstrate increased retention to ambulatory voice monitoring ...