A Personalized Voice Restoration Device for Patients With Laryngectomy

Weill Cornell Medicine (WCM)

Status: Begins enrollment in a year or more

Conditions: Dysphonia; Aphonia

Treatments: Device: Surface Electromyography

Study type: Interventional

Funder types: Other

Identifiers

NCT05479643

22-03024627

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Patients with Aphonia or Dysphonia

Experimental group

Description:

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

Treatment:

Device: Surface Electromyography

Healthy Volunteers

Placebo Comparator group

Description:

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

Treatment:

Device: Surface Electromyography