VOICE Intervention for Voice Disorders

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

70 Participants Needed

Trial Summary

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 data supports the idea that VOICE Intervention for Voice Disorders is an effective treatment?

The available research shows that voice therapy, including VOICE Intervention, is often recommended as the first choice for treating voice disorders. It is considered effective because it focuses on improving how patients perceive their voice and how it feels, which can lead to better outcomes. Although the specific studies provided do not directly compare VOICE Intervention to other treatments, they emphasize the importance of patient feedback and the use of various assessment tools to measure improvements in voice quality and patient satisfaction. ^{1 2 3 4 5}

What safety data exists for the VOICE Intervention for Voice Disorders?

The provided research does not contain specific safety data for the VOICE Intervention for Voice Disorders or its related names. The studies focus on cochlear implant complications, post-discharge care problems, safety-related drug label changes, ototoxicity monitoring, and patient-reported outcomes in safety event reporting, none of which directly address the safety of the VOICE Intervention or its variants. ^{6 7 8 9 10}

Is the VOICE Intervention Arm treatment a promising treatment for voice disorders?

Yes, the VOICE Intervention Arm treatment is promising because it uses technology to improve how voice disorders are treated. It can make diagnosing voice problems more accurate and help people use effective voice treatment methods in their daily lives. This approach is especially helpful for people who rely on their voice for work and may have trouble accessing specialists. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to pilot test a version of the intervention that has been tailored for participants with dysphonia. The study seeks to determine if the adapted intervention: a) increases perceived control over voice-related stressors and b) decreases stress and distress resulting from voice problems. The study will also explore the usability and acceptability of the program. The goal is to help people with voice problems achieve better voice and quality of life outcomes.

Research Team

Stephanie Misono, MD, MPH

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Efficacy of Novafon Local Vibration Voice Therapy and Water Resistance Therapy: a meta-analysis]. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Assessing Candidacy for Conversation Training Therapy: The Role of Patient Perception. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A review of outcome measurements for voice disorders. [2019]

4. Singapore pubmed.ncbi.nlm.nih.gov

Multi-dimensional investigation of the clinical effectiveness and prognostic factors of voice therapy for benign voice disorders. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Acoustic Voice Analysis and Maximum Phonation Time in Relation to Voice Handicap Index Score and Larynx Disease. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Identifying patients with post-discharge care problems using an interactive voice response system. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Safety-Related Drug Label Changes Following Large Post-Marketing Cardiometabolic Trials: A Review of European Public Assessment Reports. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The current state of ototoxicity monitoring in New Zealand. [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Voice therapy methods in dysphonia. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The Next 10 Years in Voice Evaluation and Treatment. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

The ageing voice and voice therapy in geriatrics. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Technology in the assessment of voice disorder. [2011]

15. United States pubmed.ncbi.nlm.nih.gov

Voice therapy. Techniques and applications. [2004]