Voice Restoration Device for Loss of Voice

Overseen By Sara W Albert, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Face muscle paralysis

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to restore speech for individuals who have lost their voice or face severe voice issues. The Personalized Voice Restoration Device uses machine learning and special sensors on the face and neck to interpret silent speech. Researchers seek participants with severe voice problems, such as aphonia (complete loss of voice) or dysphonia (difficulty speaking), to determine if the device can aid communication. A comparison group of healthy volunteers without voice issues will also participate. This trial may suit those with significant voice challenges affecting daily communication. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could transform communication for individuals with severe voice issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this voice restoration device is safe?

Research has shown that the Personalized Voice Restoration Device has been tested for effectiveness and safety. In an initial study, the device, which enables speech without vocal cords, functioned effectively with custom sensor placements. This indicates that the device is generally easy for patients to use and safe.

Since the trial is in the "Not Applicable" phase, it focuses mainly on early testing and safety. While the device appears promising, information about its long-term effects remains limited. However, current studies have not identified any serious side effects, which is a positive indicator of its safety.

Overall, the device appears to be a safe and promising option for those seeking to restore their voice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for voice loss, like speech therapy or surgery, focus on improving the vocal cords themselves. Unlike these conventional methods, the Personalized Voice Restoration Device uses surface electromyography (sEMG) sensors attached to the articulatory muscles. This innovative approach captures muscle signals to help restore voice function, offering a more tailored and potentially effective solution for individuals with aphonia or dysphonia. Researchers are excited because this method could significantly improve communication for those who have lost their voice, providing a custom-fit solution that directly targets muscle activity involved in speech.

What evidence suggests that this voice restoration device is effective for loss of voice?

Research has shown that the Personalized Voice Restoration Device, which participants in this trial may use, could assist people who have lost their voice. A small initial study found that sensors placed on the face and neck can detect silent speech, marking a significant advancement for those unable to speak normally. Another study indicated that machine learning can enable speech without using vocal cords. This suggests the device might help people communicate again if they have lost their voice or have trouble speaking. Although data remains limited, these early results are promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Anais Rameau, M.D

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am an adult with severe voice issues or a voice condition score above 0.

I am 18 or older and do not have any voice impairments.

Exclusion Criteria

My facial muscles are completely paralyzed, affecting my ability to speak.

I am healthy but have a voice impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Procedure

Participants recite phrases with sEMG attached to articulatory muscles, and acoustic and signal data are captured

1 visit

1 visit (in-person)

Qualitative Interview

Participants complete a semi-structured interview about their experience with voice restoration devices

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate feedback or reactions post-procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Voice Restoration Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients with Aphonia or Dysphonia Experimental Treatment 1 Intervention

Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles.

Group II: Healthy Volunteers Placebo Group 1 Intervention

Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Citations

1. withpower.com withpower.com/trial/phase-aphonia-7-2022-6c5af

Voice Restoration Device for Loss of Voice Although specific effectiveness data for the Personalized Voice Restoration Device is not provided, the moral and ethical case for developing such technology is ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31876090/

Pilot study for a novel and personalized voice restoration ... This pilot study demonstrates the feasibility of sEMG-based alaryngeal speech recognition, using tailored sensor placement and a personalized wearable device.

3. calhns.com calhns.com/blog/how-a-machine-may-cure-your-voice-problems/?bp=46639

How a Machine May Cure Your Voice Problems After the MTD group received vocal therapy, their speech patterns were restored to closely match those of the control group. The success of this ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0196070925000298

Tele-voice therapy. Application of the tele-medicine ... The available studies seem to support tele-speech therapy as an effective tool for selected dysphonia patients.

5. nature.com nature.com/articles/s41467-024-45915-7

Speaking without vocal folds using a machine-learning- ... We present a self-powered wearable sensing-actuation system based on soft magnetoelasticity that enables assisted speaking without relying on the vocal folds.

6. mdpi.com mdpi.com/2072-6694/14/3/544

Comprehensive Evaluation of Vocal Outcomes and Quality ... This study aimed to analyze both techniques' subjective and objective vocal outcomes and their impact on overall and voice-related quality of life.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1574119217301918

Serious game based personalized healthcare system for ... The assistive tool employs serious games as the attractive logic part, and running on the tablet with normal microphone and/or Kinect2 as voice input device.