Back to resultsA Personalized Voice Restoration Device for Patients With Laryngectomy
Primary Purpose
Dysphonia, Aphonia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surface Electromyography
Sponsored by
About this trial
This is an interventional supportive care trial for Dysphonia
Eligibility Criteria
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
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patients with Aphonia or Dysphonia
Healthy Volunteers
Arm Description
Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles.
Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05479643
First Posted
July 25, 2022
Last Updated
April 5, 2023
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT05479643
Brief Title
A Personalized Voice Restoration Device for Patients With Laryngectomy
Official Title
A Pilot Study for a Novel and Personalized Voice Restoration Device for Patients With Laryngectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia, Aphonia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Aphonia or Dysphonia
Arm Type
Experimental
Arm Description
Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles.
Arm Title
Healthy Volunteers
Arm Type
Placebo Comparator
Arm Description
Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles.
Intervention Type
Device
Intervention Name(s)
Surface Electromyography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Words and Numbers Correctly Identified
Description
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"
Title
Subject experience with voice restoration devices: Qualitative
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anais Rameau, M.D.
Phone
16469627464
Email
anr2783@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hal D Rives, B.S.
Phone
6469627464
Email
har4001@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anais Rameau, M.D
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Personalized Voice Restoration Device for Patients With Laryngectomy
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