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Ambulatory Voice Biofeedback for Voice Disorders
N/A
Recruiting
Led By Robert E Hillman, PhD
Research Sponsored by Massachusetts General Hospital
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 6 weeks
Awards & highlights
Study Summary
This trial will enroll patients with nodules and those with muscle tension dysphonia. These two groups will receive ambulatory voice biofeedback throughout 6 weeks of voice therapy. The targeted objective voice measure during biofeedback will be individually tailored with the goal of increased percentage compliance.
Who is the study for?
This trial is for English-speaking patients who are undergoing voice therapy due to vocal fold nodules or muscle tension dysphonia. Participants must have baseline voice data that deviates from the norm by at least one standard deviation.Check my eligibility
What is being tested?
The study tests ambulatory voice biofeedback over a period of 6 weeks during regular voice therapy sessions. The feedback aims to help patients comply with targeted voice measures, which will be customized for each individual.See study design
What are the potential side effects?
Since this intervention involves non-invasive biofeedback during therapy, significant side effects are not anticipated. However, participants may experience frustration or stress if they struggle with compliance or adapting to the technology.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent compliance
Trial Design
3Treatment groups
Experimental Treatment
Group I: Week 5 startExperimental Treatment1 Intervention
For the first four weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In voice therapy week 5, patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate "washout" and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2.
Group II: Week 4 startExperimental Treatment1 Intervention
For the first three weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In voice therapy weeks 4 and 5, patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate "washout" and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2.
Group III: Week 3 startExperimental Treatment1 Intervention
For the first two weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In the following 3 weeks of voice therapy (weeks 3 through 5), patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate "washout" and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ambulatory voice biofeedback
2017
N/A
~30
Find a Location
Who is running the clinical trial?
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,257 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,307 Total Patients Enrolled
Robert E Hillman, PhDPrincipal Investigator - Mass General Hospital, Harvard, MGH IHP
Massachusetts General Hospital
1 Previous Clinical Trials
29 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand English, as the study uses an English-only app.I am receiving voice therapy for vocal fold nodules or muscle tension in my voice.If your baseline ambulatory monitoring data is not significantly different from a normal database, you will be excluded.
Research Study Groups:
This trial has the following groups:- Group 1: Week 3 start
- Group 2: Week 5 start
- Group 3: Week 4 start
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many participants is this experiment recruiting?
"Indeed, according to clinicaltrials.gov this study is still in the process of recruiting patients. Originally posted on June 1st 2018, it also underwent an update as recently as August 22nd 2022 and needs a total of 48 subjects from one centre."
Answered by AI
Do I meet the qualifications to take part in this research effort?
"A total of 48 individuals aged 18-65 with dysphonia are needed for this study. Participants must have either vocal fold nodules or muscle tension dysphonia and be undergoing voice therapy treatment."
Answered by AI
Is the trial still admitting individuals for participation?
"Affirmative. Clinicaltrials.gov shows that this clinical trial is in the midst of recruitment efforts, having been first published on June 1st 2018 and last edited on August 22nd 2022. The study requires 48 participants to be enrolled from one location."
Answered by AI
Is this investigation open to individuals aged fifty or over?
"This trial is open to those aged 18 to 65, though there are 4 clinical trials available for minors and 26 studies accessible by seniors."
Answered by AI
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