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VOICE Intervention for Voice Disorders
N/A
Recruiting
Led By Stephanie Misono, MD, MPH
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks to 2 years
Awards & highlights
Study Summary
This trial is testing a new intervention specifically for people with voice problems, to see if it can help them feel more in control and less stressed about their condition.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focusing on stress management through technology-based programs rather than drugs or surgery, side effects are not typical but may include discomfort using the technology or emotional distress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perceived Control
Secondary outcome measures
Perceived Stress
Psychological Symptoms
Voice Handicap
Other outcome measures
Intervention Module Acceptability
Patients' Adherence to Voice Therapy and Treatment
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VOICE Intervention ArmExperimental Treatment1 Intervention
Participants participate in the online VOICE program to learn about perceived control and stress reduction to improve voice outcomes.
Group II: Information-Only ArmPlacebo Group1 Intervention
Participants participate in the information only program to learn about voice problems, anatomy and physiology.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,675 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,401 Total Patients Enrolled
3 Trials studying Voice Disorders
1,314 Patients Enrolled for Voice Disorders
Stephanie Misono, MD, MPHPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need new medications that might change my voice.I have a speech therapy appointment within the next two weeks.I am willing to use an online program for my treatment.I am pregnant.I am able to understand and agree to the study's procedures and risks.I am between 18 and 80 years old and have a voice issue.You have a high score (more than 10) on the Voice Handicap Index (VHI-10).I am not receiving other treatments that could affect the study.I am currently participating in speech therapy.I can understand and agree to the study's consent form.I need immediate surgery or treatment for a throat problem.People who have Muscle Tension Dysphonia and are being treated at specific clinics.
Research Study Groups:
This trial has the following groups:- Group 1: VOICE Intervention Arm
- Group 2: Information-Only Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible for inclusion in this research endeavor?
"To partake in this study, participants must be suffering from dysphonia and between 18 to 80 years of age. Currently, 70 individuals are desired for the trial."
Answered by AI
Would this research endeavor be accessible to subjects at present?
"Per the clinicaltrials.gov website, this medical trial is currently seeking patients to enroll in it. The research was initially announced on April 11th 2016 and has been amended most recently on February 9th 2022."
Answered by AI
Does this research include elderly individuals as participants?
"This clinical trial is looking for patients aged 18 to 80. There are additional trials targeting younger and older age brackets, including 3 studies catering exclusively to those under the tender legal age of consent and 33 specifically designed for participants over 65 years old."
Answered by AI
How many individuals have been enrolled into the research trial thus far?
"Affirmative. Data on clinicaltrials.gov reveals that this medical trial is currently enrolling participants, having first been published on April 11th 2016 and most recently updated on February 9th 2022. To facilitate the study, 70 patients are required between two research sites."
Answered by AI
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