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

EMG Voice Restoration

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.

Study Overview

• Status: Completed
• Conditions: Speech Disorders; Speech Perception; Rehabilitation of Speech and Language Disorders; Speech, Alaryngeal; Communication Aids for Disabled; Speech Intelligibility
• Intervention / Treatment: Device: Experimental System: MyoVoice; Device: Reference System: Electrolarynx

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • Altec Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental and Reference Devices for Communication; 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.	Device: Experimental System: MyoVoice; Person-centric augmentative and alternative communication (AAC) system comprising a user-specific set of wearable sensors for capturing articulatory muscle activity and mobile software that provides real-time audible speech outputs.; Device: Reference System: Electrolarynx; Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
No Intervention: Development of Speech Corpora; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pitch Recognition Accuracy	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%.	30 mins to 2 hours
Loudness Recognition Accuracy	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%.	30 mins to 2 hours
Speech Naturalness	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%.	30 mins to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MyoVoice Translation Speed	Duration in which the MyoVoice system carries out sEMG-to-speech synthesis relative to the length and content of the message being synthesized.	1 hour
Acceptability	The degree to which naïve listeners find a speech sample to be "acceptable" relative to attributes of pitch, rate, understandability and voice quality.	1 hour
Acoustic Identity	The accuracy in which naïve listeners select which voice sample best matches that of a presented speech sample.	1 hour
Emotional Content	Naïve listeners will complete a single multiple-choice question to qualitatively assess the perceived emotional content conveyed by each speech sample. Listeners will select a single emotion they feel BEST represents that which was conveyed by the speech sample from a list of the seven fundamental emotions of "sadness," "anger," "happiness," "disgust," "surprise," "fear," and "neutral."	1 hour
Prosodic sEMG-Acoustic Correlation	Correlation between recognized (sEMG) and ground-truth (acoustic) prosodic tone and break indices (ToBI) measured during speaking tasks.	1 hour

Collaborators and Investigators

• Sponsor: Altec Inc.
• Investigators: Principal Investigator: Gianluca DeLuca, Altec Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders
• Other Study ID Numbers: EMG Voice Restoration

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant demographics, summary data for all primary and secondary outcome measures, and study protocol will be made available.
• IPD Sharing Time Frame: Data will be made available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access request will be made through conferencing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No