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

Altec

Status: Completed

Conditions: Speech Perception; Speech Intelligibility; Speech Disorders; Communication Aids for Disabled; Speech, Alaryngeal; Rehabilitation of Speech and Language Disorders

Treatments: Device: Reference System: Electrolarynx; Device: Experimental System: MyoVoice

Study type: Interventional

Funder types: Industry

Identifiers

NCT04762043

EMG Voice Restoration

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Individuals without Laryngectomy ("Controls")

   Inclusion Criteria:

   • 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 decibels (dB) hearing level (HL) at 125, 250, 500, 1000, 2000, 4000, and 8000 Hz based on the American Speech-Language-Hearing Association)
   • Capable of signed informed consent

   Exclusion Criteria:

   • Inability to understand spoken English or follow simple instructions
   • History of speech, language, cognitive, or hearing disorders
   • Inability to provide written informed consent

2. Individuals with Laryngectomy

Inclusion Criteria:

• At least 6 months S/P total laryngectomy
• Primary English speaker
• Proficient with an electrolarynx (EL)
• Sufficiently available and healthy to comply with multiple test sessions lasting 4-6 hours
• Capable of signed informed consent

Exclusion Criteria:

• Inability to understand spoken English or follow simple instructions
• Loss of adequate surface electromyographic (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
• Any other medical or psychological condition that is based on the opinion of investigations 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)
• Inability to provide written informed consent

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental and Reference Devices for Communication

Experimental group

Description:

Each participant listens to speech produced by an experimental ("MyoVoice") and reference (electrolarynx) systems that are used to communicate. Participants rate the naturalness of the speech produced from each device (audio files presented in a randomized order). Duration: 30 mins to 1 hour.

Treatment:

Device: Experimental System: MyoVoice

Device: Reference System: Electrolarynx

Development of Speech Corpora

No Intervention group

Description:

Each participant produces a list of speech tasks that include syllables, phrases, reading passages, and open-ended questions using the MyoVoice system. Myovoice pitch and loudness recognition accuracy of speech is evaluated. Duration: 30 mins to 2 hours.