VOICE Intervention for Voice Disorders

No longer recruiting at 1 trial location

Overseen By Ali Stockness, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: New voice-related medications

Disqualifiers: Concurrent treatment, Pregnant, Prisoner, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program designed to assist individuals with muscle tension dysphonia, a condition that makes speaking difficult. The goal is to determine if the program can help users feel more in control of their voice problems and reduce stress related to speaking. Participants will either engage with the VOICE Intervention, which focuses on managing stress and voice control, or an information-only program about voice issues. The trial seeks individuals diagnosed with muscle tension dysphonia who struggle with voice issues and have reliable internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance voice management for many.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you need new medications that may directly affect voice-related symptoms, you may be excluded from participating.

What prior data suggests that this intervention is safe for individuals with voice disorders?

Research shows that the VOICE Intervention is safe for participants. Although specific safety details for this program aren't available, the intervention is non-invasive, meaning it doesn't involve surgery or medication. Instead, it uses online learning to help manage stress and improve voice control.

Previous studies on similar voice therapy programs have not reported major safety issues. These programs usually include voice training and stress management, which most people handle well. Since the VOICE Intervention is in the "Not Applicable" phase, it likely involves minimal risk. This phase typically indicates the treatment is not expected to cause harmful effects.

Overall, the intervention appears safe based on its design and the lack of reported safety concerns in similar therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional voice disorder treatments that often involve in-person therapy sessions, the VOICE Intervention is unique because it leverages an online platform to teach participants about perceived control and stress reduction. This digital approach allows for increased accessibility and flexibility, enabling individuals to engage with the program from the comfort of their homes. Researchers are excited about this method as it not only potentially improves voice outcomes but also empowers participants by giving them tools to manage stress, which is a crucial factor in voice disorders.

What evidence suggests that the VOICE Intervention could be effective for dysphonia?

Research shows that online therapy for voice problems can yield positive results. In this trial, participants in the VOICE Intervention Arm will engage in an online program designed to improve voice outcomes by teaching perceived control and stress reduction techniques. Studies have found that voice therapy often leads to significant improvements, including better stress management related to voice issues and reduced distress. Behavioral voice therapy, which teaches new ways to use the voice, typically enhances vocal function. The VOICE program aims to increase participants' sense of control and reduce stress about voice problems, potentially improving quality of life. Meanwhile, participants in the Information-Only Arm will learn about voice problems, anatomy, and physiology without the tailored intervention. ^{1 6 7 8 9}

Who Is on the Research Team?

Stephanie Misono, MD, MPH

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with Muscle Tension Dysphonia, who experience voice problems and score high on the Voice Handicap Index. Participants must be able to consent, want to use an online program, and have internet access. It excludes those needing urgent voice treatment, scheduled speech therapy soon, starting new meds affecting the voice, pregnant women, prisoners or anyone unable to consent.

Inclusion Criteria

I am willing to use an online program for my treatment.

Has reliable access to internet

You have a high score (more than 10) on the Voice Handicap Index (VHI-10).

Exclusion Criteria

I need new medications that might change my voice.

I have a speech therapy appointment within the next two weeks.

Prisoner

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete an initial baseline assessment focused on voice function and emotions

1 week

1 visit (virtual)

Intervention

Participants complete online check-ins and exercises or quizzes twice a week for up to three weeks

3 weeks

6 visits (virtual)

Post-Intervention Assessment

Participants complete a post-intervention assessment parallel to the baseline assessment

1 week

1 visit (virtual)

Follow-up

Follow-up with each participant will occur one and three months after finishing the program

3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Information-Only Arm
• VOICE Intervention Arm

Trial Overview

The study tests a tailored intervention for dysphonia that aims to increase control over voice-related stress and reduce distress from voice issues. It compares a VOICE Intervention Arm with an Information-Only Arm regarding their impact on stress management and quality of life related to vocal health.

How Is the Trial Designed?

Group I: VOICE Intervention Arm Experimental Treatment 1 Intervention

Participants participate in the online VOICE program to learn about perceived control and stress reduction to improve voice outcomes.

Group II: Information-Only Arm Placebo Group 1 Intervention

Participants participate in the information only program to learn about voice problems, anatomy and physiology.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Medical oncologists and audiologists in New Zealand have a good understanding of ototoxicity, but there is a lack of familiarity with monitoring protocols, leading to inconsistent practices across District Health Boards (DHBs).

Most participants (22 out of 23) support the creation of a national ototoxicity monitoring guideline, which could standardize practices and potentially improve audiological outcomes for patients undergoing ototoxic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current state of ototoxicity monitoring in New Zealand. Steffens, L., Venter, K., O'Beirne, GA., et al.[2018]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

Voice therapy is an effective first-line treatment for benign voice disorders such as vocal nodules, polyps, and muscle tension dysphonia, with significant improvements in voice quality and patient-reported outcomes after treatment.

Adherence to voice therapy sessions and the level of vocal demand in a patient's occupation are important factors that influence treatment success, with higher adherence and greater vocal demand leading to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-dimensional investigation of the clinical effectiveness and prognostic factors of voice therapy for benign voice disorders. Lin, FC., Chien, HY., Kao, YC., et al.[2021]

Acoustic voice analyses, including measures like jitter, shimmer, and Noise-to-Harmonic ratio (NHR), are effective in distinguishing between different types of voice-related disorders in patients, as shown in a study of 208 participants with various larynx conditions compared to 98 healthy controls.

Maximum phonation time (MPT) and the Voice Handicap Index (VHI) scores were found to correlate with acoustic measures, providing valuable insights into the severity of voice disorders, particularly in cancer and degenerative/inflammatory patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acoustic Voice Analysis and Maximum Phonation Time in Relation to Voice Handicap Index Score and Larynx Disease. Karlsen, T., Sandvik, L., Heimdal, JH., et al.[2020]

Both Novafon Local Vibration Voice Therapy (NLVVT) and Water Resistance Therapy (WRT) significantly improved voice disorder symptoms in adult patients, as measured by the Voice Handicap Index (VHI).

In a direct comparison, NLVVT showed greater improvements in overall voice handicap (VHI total), functional (VHI-F), and emotional (VHI-E) aspects compared to WRT, indicating it may be a more effective treatment option for voice disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of Novafon Local Vibration Voice Therapy and Water Resistance Therapy: a meta-analysis]. Latoszek, BBV., Hetjens, S.[2023]

In a study of 91 elderly patients (ages 50-91) with voice complaints, vocal nodules were the most common diagnosis, highlighting the prevalence of this condition in geriatric dysphonia.

The study found that 80% of patients received hygienic voice therapy, indicating its common use, but further research is needed to establish normative voice measures for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ageing voice and voice therapy in geriatrics. Çiyiltepe, M., Şenkal, ÖA.[2018]

Voice therapy encompasses various behavioral techniques aimed at treating voice disorders, providing a range of methods tailored to different conditions.

The article outlines specific therapy techniques, including their rationale and expected outcomes, to help practitioners effectively apply these methods in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice therapy methods in dysphonia. Casper, JK., Murry, T.[2019]

Voice therapy is essential for treating both functional and organic voice disorders, highlighting the critical role of speech pathologists in patient care.

The article reviews various treatment options and techniques, including voice rest, that can be applied to effectively manage voice disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice therapy. Techniques and applications. Prater, RJ.[2004]

An interactive voice response system (IVRS) successfully identified 21% of elderly patients post-discharge who required follow-up, indicating its potential utility in monitoring patient safety after hospital discharge.

Despite the IVRS being well-received by patients (97% found it easy to use), it only detected 9% of actual adverse events (AEs), suggesting that additional monitoring strategies are needed to effectively capture more AEs and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying patients with post-discharge care problems using an interactive voice response system. Forster, AJ., Boyle, L., Shojania, KG., et al.[2021]

Voice disorders affect about one third of people in the U.S., especially those who rely on their voice for work, highlighting the need for better diagnosis and treatment.

Technological advancements in laryngeal imaging, personalized vocal pattern modeling, and telehealth are expected to significantly enhance the accuracy of voice disorder diagnoses and improve treatment effectiveness in everyday communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Next 10 Years in Voice Evaluation and Treatment. Barkmeier-Kraemer, JM., Patel, RR.[2018]

The article outlines various advanced technologies for assessing voice disorders, including measurements of jitter, shimmer, harmonic-to-noise ratio, and laryngeal airflow, which are crucial for accurate diagnosis and treatment planning.

Clinical case examples demonstrate how these technologies enhance the understanding and management of voice disorders, highlighting their importance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology in the assessment of voice disorder. Case, JL.[2011]

A retrospective analysis of cochlear implant adverse events over a 10-year period revealed a significant increase in cases with multiple or unknown causes, particularly gradual idiopathic loss of performance, indicating a shift in the nature of reported issues.

Despite improvements in manufacturing and surgical techniques, the rise in complex adverse events suggests a need for further research to understand and address these idiopathic cases to enhance cochlear implant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. Causon, A., Verschuur, C., Newman, TA.[2013]

A study of 55 large clinical trials involving over 402,000 patients found that 69% resulted in updates to the safety information on drug labels for cardiometabolic agents, indicating that these trials can provide valuable safety data post-approval.

However, the overall contribution of these trials to new safety information was limited, with only 35% leading to changes in adverse drug reactions, suggesting that selective safety data collection may not significantly enhance safety knowledge for drugs already studied extensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety-Related Drug Label Changes Following Large Post-Marketing Cardiometabolic Trials: A Review of European Public Assessment Reports. Starokozhko, V., Tarrahi, F., Vrijlandt, PJWS., et al.[2023]

In a study of 50 patients with muscle tension dysphonia and benign vocal fold lesions, voice therapy (conversation training therapy) led to significant improvements in voice handicap index (VHI-10) scores, indicating effective rehabilitation.

Patients who perceived a positive change in the feel of their voice during initial stimulability assessments tended to show faster recovery, suggesting that self-perception plays a crucial role in the effectiveness of voice therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Candidacy for Conversation Training Therapy: The Role of Patient Perception. Shelly, S., Rothenberger, SD., Gartner-Schmidt, J., et al.[2023]

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]

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