Online Voice Education + Vocal Hygiene for Hoarseness

Overseen By Efstratios Achlatis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Parkinson's, ALS, Hearing loss, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8-10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether online education can boost engagement in voice therapy for individuals with hoarseness. Participants will test online learning modules focused on voice quality or vocal hygiene to determine their impact on therapy participation and understanding of the treatment. Individuals diagnosed with voice issues (dysphonia) and preparing to start voice therapy may be suitable candidates, particularly if they have internet access and can engage with the online content. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future voice therapy experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these online modules are safe for participants?

Research has shown that online voice education programs are generally safe and easy to use. One study with student teachers using a similar online program for voice health found no negative effects, suggesting that learning about voice care online is safe. Participants reported benefits without any problems.

The vocal hygiene module, a common part of voice therapy, teaches simple habits to protect and care for the voice. This type of learning carries no known risks.

Overall, both the online voice education program and the vocal hygiene module are expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the online voice education and vocal hygiene modules for hoarseness because they offer a novel, accessible way to potentially improve vocal health. Unlike traditional speech therapy that requires in-person visits, these online modules allow patients to engage in self-assessment and learning from home, making it more convenient. The education module focuses on helping patients understand and rate their vocal quality, while the vocal hygiene module promotes healthy vocal habits. This approach not only aims to enhance treatment outcomes but also empowers patients with knowledge and self-efficacy regarding their vocal health.

What evidence suggests that this trial's treatments could be effective for hoarseness?

Research has shown that online learning tools can positively affect voice therapy. In this trial, participants in the Experimental Group will complete an online voice quality education module, which studies have found can greatly improve vocal quality compared to no training. Specifically, a program designed to prevent voice issues successfully helped student teachers improve their voice quality. Meanwhile, participants in the Sham Control Group will complete a module focusing on vocal hygiene. Although some studies did not find clear results for preventing hoarseness, the overall evidence supports that structured voice training can improve vocal outcomes. By increasing understanding and involvement, these educational tools might enhance participation in voice therapy. ^{1 6 7 8 9}

Who Is on the Research Team?

Aaron Johnson, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with hoarseness (dysphonia) who are recommended voice therapy. They must have internet access and be willing to complete all assessments. It's not for those with certain neurological conditions, moderate-to-profound hearing loss, visual impairments that prevent online module completion, or previous voice quality rating training.

Inclusion Criteria

Willingness to complete all clinical/research assessments

I have been diagnosed with voice disorders and advised to undergo voice therapy.

I am older than 18 years.

Exclusion Criteria

I have been diagnosed with Parkinson's Disease or another progressive neurodegenerative disorder.

Previous training in acoustic-perceptual voice quality rating, for example a speech language pathology student

I will have surgery as part of my treatment plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Treatment

Participants complete an online module focusing on patient self-rating of vocal quality within 24 hours of evaluation and approximately 1-2 weeks prior to their first therapy session

1-2 weeks

Online module completion

Treatment

Participants undergo voice therapy sessions, with online module completion within 24 hours after each session

8-10 weeks

Multiple therapy sessions (in-person)

Follow-up

Participants are monitored for changes in voice handicap perception and therapy effectiveness

Up to 4 months from baseline

Final assessment visit

What Are the Treatments Tested in This Trial?

Interventions

• Online Voice quality education module
• Vocal hygiene module

Trial Overview The study tests if adding educational online modules about voice quality and vocal hygiene can improve patient engagement in voice therapy. The goal is to see if this approach helps patients better understand their treatment plan and potentially leads to better attendance and outcomes in therapy.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Participants will complete an online module with content focusing on patient self-rating of vocal quality within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session;

Group II: Control group Active Control 1 Intervention

Participants will not complete an online module. The groups will be compared in terms of attendance, self-efficacy, and treatment outcome measures based on the data collected within the NYU Voice Center standard of care

Group III: Sham Control Group Placebo Group 1 Intervention

Participants will complete an online module within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session with content focusing on vocal hygiene.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Patient-based outcome measures, like quality-of-life and handicap indexes, are crucial for assessing initial disability and treatment responses in patients with voice disorders, as traditional methods have limitations.

This review emphasizes the importance of these measures in laryngology and provides detailed discussions on various voice-specific instruments to help otolaryngologists improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of outcome measurements for voice disorders. Hogikyan, ND., Rosen, CA.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05237648

Assessing the Effects of Patient Self-Rating of Voice Quality ... The purpose of this study is to assess the effects of incorporating educational online modules into voice therapy. One of the main reasons that voice ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5590670/

An Online Telepractice Model for the Prevention of Voice ... This article describes the Global Voice Prevention Model (GVPM) facilitated with student teachers at West Chester University and the VoiceEvalU8 smartphone ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36494244/

The Effectiveness of Vocal Health Programs in ... Results of this study were not considered significant to conclude on the effectiveness of voice training for preventing dysphonia in teachers.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199709001337

Review of the Impact of Voice Training on the Vocal Quality ... Five studies reported that voice training significantly (P < 0.05) improved at least one measurement compared with no training. Conclusions. Findings indicate ...

5. uwo.ca uwo.ca/fhs/lwm/teaching/EBP/2015_16/Strande.pdf

Are dysphonia prevention training programs effective in ... Overall, this study presented compelling evidence for the efficacy of an integrated dysphonia prevention program in improving voice quality in student teachers.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9376341/

Effects of Virtual Instruction on Educators' Voices During the ... This study compared the symptoms of vocal tract discomfort and self-perceived voice handicap in full-time educators between face-to-face and virtual settings.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0892199725003868

Has Research Failed to Identify Risk Factors for Voice ... This systematic review examined risk factors for voice disorders among K-12 teachers. It analyzed 111 publications from 33 countries that ...

8. thesportjournal.org thesportjournal.org/article/voice-health-in-pre-service-physical-education-majors-a-pilot-study/

Voice Health in Pre-Service Physical Education Majors The purpose of this study was to pilot an online training module targeting student teachers before they entered their teaching professions.

9. pubs.asha.org pubs.asha.org/doi/10.1044/2025_AJSLP-25-00140

The Accuracy of Smartphone Recordings for Clinical Voice ... Clinical voice quality assessments typically use external microphones meeting technical standards for instrumental assessment of voice.