A Personalized Voice Restoration Device for Patients With Laryngectomy

N/ANot Yet RecruitingNCT05479643

Weill Medical College of Cornell University100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

100

Conditions

Dysphonia Aphonia

Interventions

Surface ElectromyographyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Weill Cornell Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: "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.

Time frame: 10 minutes after the time of intervention

Central Contacts

Anaïs Rameau, MD

CONTACT

646-962-7464 anr2783@med.cornell.edu

Data from ClinicalTrials.gov

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