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Muscle Activity Analysis for Hoarseness
N/A
Waitlist Available
Led By Aaron Johnson
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Control Group: Age >18 years
Experimental Group: Patient cohorts diagnosed with unilateral vocal cord paralysis with a recommended treatment of vocal fold injection medialization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, 2 week visit, 2 months visit
Awards & highlights
Study Summary
This trial will help improve our understanding of how the muscles of the head and neck work during typical and atypical vocalization, which will lead to better diagnosis and treatment of dysphonia.
Who is the study for?
This trial is for adults over 18 with muscle tension dysphonia or unilateral vocal cord paralysis, recommended for voice therapy or vocal fold injection medialization. Participants must be able to consent and complete assessments. Excluded are those with allergies to the device, 'smart' implants, recent head/neck surgery, open wounds near sensors, abnormal laryngeal structures, or involvement in other investigational studies.Check my eligibility
What is being tested?
The study aims to develop a new diagnostic tool by measuring muscle activity in the neck and head using surface electromyogram (sEMG) and flexible laryngoscopy. It will compare typical voicing against disordered conditions before and after vocal fatigue to understand neuromuscular mechanisms better.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing sEMG sensors or undergoing flexible laryngoscopy. Allergic reactions could occur if there's sensitivity to the device materials. There might also be general risks associated with clinical assessments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Select...
I have been diagnosed with one-sided vocal cord paralysis and advised to get a vocal fold injection.
Select...
I have been diagnosed with muscle tension dysphonia and advised to undergo voice therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline visit, 2 week visit, 2 months visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit, 2 week visit, 2 months visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Phonatory Effort (PPE)
Change in Pitch and Loudness levels in vocal tasks
Change in Vocal loading task
Trial Design
3Treatment groups
Experimental Treatment
Group I: Experiment 3Experimental Treatment1 Intervention
In Experiment 3 (Aim 2), the study will measure patients with unilateral vocal old paralysis, representing a neurologically impaired network, before and after a vocal fold medialization procedure.
Group II: Experiment 2Experimental Treatment1 Intervention
In Experiment 2 (Aim 2), the study will measure muscle networks in patients with muscle tension dysphonia before and after a course of voice therapy. Patients with muscle tension dysphonia represent an intact but potentially maladaptive network.
Group III: Experiment 1Experimental Treatment2 Interventions
Experiment 1 (Aim 1) will utilize a 16-channel sEMG array to characterize cervical-cranial muscle activity networks in typical speakers at baseline and after a vocal loading task. Flexible laryngoscopy will be performed to exclude any existing pathology and confirm eligibility in the healthy control group. Aim 2 will quantify how cervical muscle networks are perturbed in patients with two different types of dysphonia and examine if standard-of-care treatment restores cervical-cranial muscle networks to more typical states.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,671 Total Patients Enrolled
1 Trials studying Hoarseness
8 Patients Enrolled for Hoarseness
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
327 Previous Clinical Trials
178,125 Total Patients Enrolled
6 Trials studying Hoarseness
835 Patients Enrolled for Hoarseness
Aaron JohnsonPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery on my head or neck in the last 3 months.I am over 18 years old.I have been diagnosed with one-sided vocal cord paralysis and advised to get a vocal fold injection.I have been diagnosed with muscle tension dysphonia and advised to undergo voice therapy.I am older than 18 years.The control group includes people with a smart implant that has a microcontroller, like a pain pump or nerve stimulator.Criterion: The experimental group will receive a device with a microcontroller, like a pain pump or nerve stimulator.I had surgery on my head or neck in the last 3 months.The control group should not have any open wounds or ulcers near the sEMG sensors.You cannot wear the device because you have a known allergy to it.You do not have any vocal cord problems as shown by a special type of throat examination.My throat examination showed abnormal structure or function.You have an open wound or ulcer near the sensors used in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Experiment 1
- Group 2: Experiment 2
- Group 3: Experiment 3
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.
Does this medical trial currently have any open slots for enrolment?
"The listing on clinicaltrials.gov confirms that this particular medical trial has concluded its recruitment process, having initially been posted on September 9th 2021 and last updated 8/5/2022. Nonetheless, there are 27 other studies actively seeking participants at the present time."
Answered by AI
Does this investigation have any stipulations for elderly participants?
"To be eligible for this trial, participants must between 18 and 88 years old. In addition, there are special trials for those under 18 and over 65 to accommodate their age-specific needs."
Answered by AI
Am I eligible to participate in this clinical investigation?
"This clinical trial seeks 90 individuals suffering from dysphonia, aged between 18 and 88. Eligibility criteria include the presence of muscle tension dysphonia or unilateral vocal cord paralysis, willingness to complete all assessments and provide informed consent, as well as meeting the recommended treatments for each condition."
Answered by AI
Who else is applying?
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
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