MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments

  • STATUS
    Recruiting
  • days left to enroll
    42
  • participants needed
    28
  • sponsor
    Altec Inc.
Updated on 20 April 2022
Accepts healthy volunteers

Summary

This study will evaluate the ability of MyoVoice to replace natural speech. Referred to generally as an Augmentative and Alternative Communication (AAC) device, MyoVoice uses electrical signals recorded non-invasively from speech muscles (electromyographic, or EMG, signals) to restore communication for those with vocal impairments that resulted from surgical treatment of laryngeal and oropharyngeal cancers.

Description

Over 7.5 million people worldwide are unable to vocalize effectively. Among these individuals are cancer survivors who underwent oropharyngeal/laryngeal surgery and must rely on AAC systems such as text-to-speech applications or artificial voice prostheses as substitutes for their natural voice. Yet most of these devices struggle to convey the expressive attributes of speech (prosody), leading to poor comprehension and a lack of emotional content. The clinical trial will investigate the feasibility of MyoVoice-a novel AAC device that uses surface EMG signals to extract patterns for understanding vocabulary and expressive attributes from articulatory musculature during silently mouthed speech-to effectively restore conversational capabilities for individuals living with vocal impairments due to surgical treatment of laryngeal and oropharyngeal cancers. Patients who underwent a total laryngectomy will be asked to communicate with a conversational partner by silently mouthing words using MyoVoice. The device performance will be evaluated in terms of its ability to accurately and quickly translate articulatory muscle activity into audible speech. MyoVoice will also be compared to that of conventional electrolaryngeal speech aids (i.e., artificial larynx) to evaluate device ease-of-use, functional efficacy, and social reception.

Details
Condition Rehabilitation of Speech and Language Disorders, Speech Disorders, Speech, Alaryngeal, Communication Aids for Disabled, Speech Perception, Speech Intelligibility
Treatment MyoVoice, Electrolarynx
Clinical Study IdentifierNCT04762043
SponsorAltec Inc.
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Control Subjects
Primary English speaker
No history of speech, language, cognitive, or hearing disorders
Normal hearing (able to pass a bilateral hearing screening using a threshold of 25 dB HL at 125, 250, 500, 1000, 2000, 4000, and 8000 Hz based on the American Speech-Language-Hearing Association)
Capable of signed informed consent
Laryngectomy Subjects
At least 6 months S/P total laryngectomy
Proficient electrolarynx (EL) speaker
Primary English speaker
Sufficiently available and sufficiently healthy to comply with multiple test sessions lasting 4-6 hours
Capable of signed informed consent

Exclusion Criteria

Control Subjects
Inability to understand spoken English or follow simple instructions
History of speech, language, cognitive, or hearing disorders
Inability to provide written informed consent
Laryngectomy Subjects
Inability to understand spoken English or follow simple instructions
Loss of adequate sEMG sensor sites for recording from muscles of articulation due to Cancer treatment
Skin disorders or radiation/surgical scarring that prevent the use of medical-grade adhesive tapes for securing sensors
Inability to provide written informed consent
Any other medical or psychological condition that is based on the opinion of the investigators will prevent participation in the experiment (e.g., the candidate may have an illness that makes them fatigue easily or have difficulty to attend to visual cues)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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