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A Personalized Voice Restoration Device for Patients With Laryngectomy

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05479643
Enrollment
100
Registered
2022-07-29
Start date
2027-12-01
Completion date
2031-12-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphonia, Aphonia

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.

Interventions

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.

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes

Inclusion criteria

Group A: Healthy Volunteers 1. Adult subjects, 18 or older 2. Without any voice impairments Group B: Subjects with Aphonia or Dysphonia 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 Dysphonia 1\. Subjects whose face muscles are entirely paralyzed

Design outcomes

Primary

MeasureTime frameDescription
Subject experience with voice restoration devices: Qualitative10 minutes after the time of interventionSubject 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.
Percentage of Words and Numbers Correctly IdentifiedDuring Procedure/use of Surface ElectroMyoGraphyAccuracy 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.

Countries

United States

Contacts

Primary ContactAnaïs Rameau, MD
anr2783@med.cornell.edu646-962-7464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026