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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will conduct a pilot experiment for a novel and personalized method for voice restoration using machine learning applied to surface EMG (sEMG) signal from articulatory muscles of the face and the neck allowing recognition of silent speech. The investigators predict that the use novel personalized method for voice restoration will be feasible and successful for patients.

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 data supports the effectiveness of the Personalized Voice Restoration Device treatment?

The research highlights the importance of personalized voice technology in enhancing self-expression and social participation for individuals who have lost their voice. Although specific effectiveness data for the Personalized Voice Restoration Device is not provided, the moral and ethical case for developing such technology is strong, given the significant impact of voice loss on identity and communication. ^{1 2 3 4 5}

How is the Personalized Voice Restoration Device different from other treatments for voice loss?

The Personalized Voice Restoration Device is unique because it focuses on creating a synthetic voice that closely matches the user's original voice, enhancing self-expression and identity. Unlike standard voice prostheses, this device uses personalized voice technology to capture the vocal identity of the user, promoting better social integration and communication. ^{1 2 3 6 7}

Research Team

Anais Rameau, M.D

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Detection of ideal reservoir level after laryngectomy using endoilluminator in voice rehabilitation. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Native voice, self-concept and the moral case for personalized voice technology. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Provision of surgical voice restoration in England: questionnaire survey of speech and language therapists. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Do You Like Your Voice? A Population-Based Survey of Voice Satisfaction and Voice Enhancement. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment efficacy: voice disorders. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Towards personalized speech synthesis for augmentative and alternative communication. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

In vitro evaluation of a double-membrane-based voice-producing element for laryngectomized patients. [2014]