A Personalized Voice Restoration Device for Patients With Laryngectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dysphonia, Aphonia

Intervention / Treatment
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* Device: Surface Electromyography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group A: Healthy Volunteers Adult subjects, 18 or older Without any voice impairments Group B: Subjects with Aphonia or Dypshonia Adult subjects, 18 or older 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 Dypshonia 1. Subjects whose face muscles are entirely paralyzed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Aphonia or Dysphonia<br>Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles. | Device: Surface Electromyography<br>* 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.<br>|
| Placebo Comparator: Healthy Volunteers<br>Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles. | Device: Surface Electromyography<br>* 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.<br>|

What is the study measuring?
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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 |