A Personalized Voice Restoration Device for Patients With Laryngectomy

A Pilot Study for a Novel and Personalized Voice Restoration Device for Patients With Laryngectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphonia; Aphonia
• Intervention / Treatment: Device: Surface Electromyography

Detailed Description

This is a prospective pilot study evaluating the feasibility of a personalized voice restoration device and patients' experience with it. Study participation will include a one-time visit where subjects will read passages and phrases. Acoustic and signal data will be captured. Machine learning will be applied to the data to classify words. Subjects will also participate in a qualitative interview about their experience with voice restoration devices.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anaïs Rameau, MD; Phone Number: 646-962-7464; Email: anr2783@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Weill Cornell Medicine
      • Contact: Anaïs Rameau, MD; Phone Number: 646-962-7464; Email: anr2783@med.cornell.edu
      • Principal Investigator: Anais Rameau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Group A: Healthy Volunteers

1. Adult subjects, 18 or older
2. Without any voice impairments

Group B: Subjects with Aphonia or Dysphonia

1. Adult subjects, 18 or older
2. Documentation of severe dysphonia and/or aphonia, or a GRBAS score > 0 (GRBAS is a scale that can be used to assess voice quality of subjects who do not have a recorded history of dysphonia or aphonia. The GRBAS scale evaluates for grade, roughness, breathiness, asthenia, and strain).

Exclusion Criteria:

- Group A: Healthy Volunteers

1. Voice impairment

Group B: Subjects with Aphonia or Dysphonia

1. Subjects whose face muscles are entirely paralyzed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Aphonia or Dysphonia; Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles.	Device: Surface Electromyography; Surface ElectroMyoGraphy (SEMG) is a non-invasive technique for measuring muscle electrical activity that occurs during muscle contraction and relaxation cycles. Electrodes will be attached with a AgCl gel to muscles used for articulation.
Placebo Comparator: Healthy Volunteers; Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles.	Device: Surface Electromyography; Surface ElectroMyoGraphy (SEMG) is a non-invasive technique for measuring muscle electrical activity that occurs during muscle contraction and relaxation cycles. Electrodes will be attached with a AgCl gel to muscles used for articulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Words and Numbers Correctly Identified	Accuracy of sEMG signal will be determined by subjects reciting common phrases. Subjects will recite the "Rainbow Passage" 10 times. Subjects will be asked to count from 1-10 once. Subjects will recite the alphabet once.	"During Procedure/use of Surface ElectroMyoGraphy"
Subject experience with voice restoration devices: Qualitative	Subject will be asked to complete a semi-structured interview about their experience with voice restoration devices. Categories of response include voice/communication history, experience with previous voice restoration devices, experience with our device, and suggestions for improvement.	10 minutes after the time of intervention

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Anaïs Rameau, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Voice Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dysphonia; Aphonia; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Myography; Electromyography
• Other Study ID Numbers: 22-03024627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes