A Personalized Voice Restoration Device for Patients With Laryngectomy

Dysphonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05479643
• Other study ID #: 22-03024627
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Anais Rameau, M.D.
• Phone: 6469627464
• Email: anr2783[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

Group A: Healthy Volunteers

1. Adult subjects, 18 or older

2. Without any voice impairments

Group B: Subjects with Aphonia or Dypshonia

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 Dypshonia

1. Subjects whose face muscles are entirely paralyzed

Related Conditions & MeSH terms

• Aphonia
• Dysphonia

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"
Primary	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