Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05479643

A Personalized Voice Restoration Device for Patients With Laryngectomy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10022, United States

Location contact

Anaïs Rameau, MD

CONTACT

[email protected]

646-962-7464

Anaïs Rameau, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

  • Group A: Healthy Volunteers
  • Voice impairment

Group B: Subjects with Aphonia or Dysphonia

  • Subjects whose face muscles are entirely paralyzed

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Words and Numbers Correctly Identified

    Time frame: "During Procedure/use of Surface ElectroMyoGraphy"

    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.

  2. Subject experience with voice restoration devices: Qualitative

    Time frame: 10 minutes after the time of intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anaïs Rameau, MD

CONTACT

[email protected]

646-962-7464

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2031
First posted
Jul 29, 2022
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.