A Personalized Voice Restoration Device for Patients With Laryngectomy

NCT05479643 | Not Yet Recruiting FDA Device

• 1 other identifier: 22-03024627
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphonia; Aphonia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients with Aphonia or Dysphonia

EXPERIMENTAL

Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles.

Device: Surface Electromyography

Healthy Volunteers

PLACEBO COMPARATOR

Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles.

Device: Surface Electromyography

Interventions

Surface Electromyography DEVICE

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.

Healthy Volunteers; Patients with Aphonia or Dysphonia

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group A: Healthy Volunteers
• Adult subjects, 18 or older
• Without any voice impairments
• Group B: Subjects with Aphonia or Dysphonia
• 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).

You may not qualify if:

• \- Group A: Healthy Volunteers
• \. Voice impairment
• Group B: Subjects with Aphonia or Dysphonia
• \. Subjects whose face muscles are entirely paralyzed

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Dysphonia; Aphonia

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Anaïs Rameau, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anaïs Rameau, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 29, 2022
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)