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

Not Applicable

• Conditions: Rehabilitation of Speech and Language Disorders; Speech, Alaryngeal; Speech Disorders; Communication Aids for Disabled; Speech Perception; Speech Intelligibility
• Interventions: Device: MyoVoice; Device: Electrolarynx

• Registration Number: NCT04762043
• Lead Sponsor: Altec Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-02-12
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MyoVoice Device	MyoVoice	MyoVoice Device for individuals with total laryngectomy
MyoVoice Device	Electrolarynx	MyoVoice Device for individuals with total laryngectomy

Primary Outcome Measures

Name	Time	Method
Pitch Recognition Accuracy	30 mins to 2 hours	Percent accuracy between recognized (sEMG) and ground-truth (acoustic) estimates of fundamental frequency (perceptually known as vocal pitch). Accuracy is estimated on a continuous scale from 0 to 100%.
Loudness Recognition Accuracy	30 mins to 2 hours	Percent accuracy between recognized (sEMG) and ground-truth (acoustic) estimates of intensity level (perceptually related to vocal loudness). Accuracy is estimated on a continuous scale from 0 to 100%.
Speech Naturalness	30 mins to 1 hour	Percent naturalness between MyoVoice and electrolarynx speech samples. Speech naturalness is defined based on one's "preference for how \[the audio\] sounds in terms of rate, rhythm, intonation and voice quality." Naturalness is estimated on a continuous scale from 0 to 100%.

Trial Locations

Locations (1)

Altec Inc.; 🇺🇸 Natick, Massachusetts, United States