A Personalized Voice Restoration Device for Patients With Laryngectomy

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05479643

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphonia Aphonia	Device: Surface Electromyography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Percentage of Words and Numbers Correctly Identified ["During Procedure/use of Surface ElectroMyoGraphy"]
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.
Subject experience with voice restoration devices: Qualitative [10 minutes after the time of intervention]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Voice impairment

Group B: Subjects with Aphonia or Dypshonia

Subjects whose face muscles are entirely paralyzed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator: Anais Rameau, M.D, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT05479643

Other Study ID Numbers:

22-03024627-01

First Posted:

Jul 29, 2022

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Dysphonia

Aphonia

Study Results

No Results Posted as of Jul 29, 2022