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A Personalized Voice Restoration Device for Patients With Laryngectomy

NCT ID: NCT05479643

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-12-01

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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Dysphonia Aphonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Patients with Aphonia or Dysphonia

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

Group Type EXPERIMENTAL

Surface Electromyography

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Surface Electromyography

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anaïs Rameau, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Anaïs Rameau, MD

Role: CONTACT

Phone: 646-962-7464

Email: [email protected]

Facility Contacts

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Anaïs Rameau, MD

Role: primary

Other Identifiers

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22-03024627

Identifier Type: -

Identifier Source: org_study_id