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Voice Restoration Device for Loss of Voice

N/A
Waitlist Available
Led By Anais Rameau, M.D
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Group B: Adult subjects, 18 or older with documentation of severe dysphonia and/or aphonia, or a GRBAS score > 0
Group A: Adult subjects, 18 or older without any voice impairments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes after the time of intervention
Awards & highlights

Study Summary

This trial is testing a new, personalized method for voice restoration using machine learning applied to surface EMG signals from the face and neck muscles. The investigators predict that this new method will be feasible and successful for patients.

Who is the study for?
This trial is for adults over 18 with severe voice problems or no voice at all, and those without any voice impairments. It's not suitable for healthy volunteers who have voice issues or patients whose facial muscles are completely paralyzed.Check my eligibility
What is being tested?
The study tests a new personalized device that uses machine learning to turn muscle movements of the face and neck into speech. This could help people who can't speak to communicate again.See study design
What are the potential side effects?
Since this trial involves a non-invasive device that reads muscle activity, side effects might be minimal but could include discomfort where sensors are placed or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult with severe voice issues or a voice condition score above 0.
Select...
I am 18 or older and do not have any voice impairments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~"during procedure/use of surface electromyography"
This trial's timeline: 3 weeks for screening, Varies for treatment, and "during procedure/use of surface electromyography" for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Words and Numbers Correctly Identified
Medical Devices

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Patients with Aphonia or DysphoniaExperimental Treatment1 Intervention
Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles.
Group II: Healthy VolunteersPlacebo Group1 Intervention
Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surface Electromyography
2019
N/A
~90

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,428 Total Patients Enrolled
Anais Rameau, M.DPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Personalized Voice Restoration Device (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05479643 — N/A
Hoarseness Research Study Groups: Patients with Aphonia or Dysphonia, Healthy Volunteers
Hoarseness Clinical Trial 2023: Personalized Voice Restoration Device Highlights & Side Effects. Trial Name: NCT05479643 — N/A
Personalized Voice Restoration Device (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05479643 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accommodate participants aged 45 or over?

"The parameters for inclusion in this medical trial specify that qualified participants must be aged between 18 and 110. Additionally, there are 3 studies devoted to children under the age of 18 and an additional 26 trials which focus on people over 65 years old."

Answered by AI

Are there any slots still available for enrolment in this clinical trial?

"As per records on clinicaltrials.gov, this clinical trial is no longer actively enrolling participants. The initial posting of the study was November 1st 2022 and it has been last updated October 11th 2022. Nonetheless, there are 27 other trials with open enrollment at present."

Answered by AI

Who qualifies to participate in this research program?

"This trial calls for 100 individuals with dysphonia, aged between 18 and 110. Most notably, they must meet the following criteria: Group A - adult subjects without any vocal impediments; Group B - those who can present evidence of serious aphonia or dyshphonia as well as a GRBAS score that surpasses 0 (the GRBAS is an evaluation instrument to assess voice quality in persons without prior history of either condition)."

Answered by AI

Who else is applying?

What site did they apply to?
Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Looking for a second opinion on my swallowing problem.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Personalized Voice Restoration Device for Patients With Laryngectomy
2024. "A Personalized Voice Restoration Device for Patients With Laryngectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05479643.
~67 spots leftby Oct 2024
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