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: Recruiting
• Conditions: Speech Disorders; Speech Perception; Rehabilitation of Speech and Language Disorders; Speech, Alaryngeal; Communication Aids for Disabled; Speech Intelligibility
• Intervention / Treatment: Device: MyoVoice; Device: 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 (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer M Vojtech, PhD; Phone Number: 5085458208; Email: jvojtech@altecresearch.com
• Study Contact Backup: Name: Serge H Roy; Phone Number: 5085458235; Email: sroy@delsys.com

Study Locations

• United States
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • Recruiting
      • Altec Inc.
      • Contact: Serge H Roy; Phone Number: 5085458235; Email: sroy@delsys.com
      • Contact: Jennifer M Vojtech, PhD; Phone Number: 508-545-8208; Email: jvojtech@altecresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyoVoice Device; MyoVoice Device for individuals with total laryngectomy	Device: MyoVoice; Person-centric 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: Electrolarynx; Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Word Recognition Rate	Accuracy of identifying individual words from a designated speech corpus that are automatically transcribed using the AAC device.	1 hour
Prosody Recognition Rate	Accuracy of identifying prosodic tone and break index (ToBI) categories from a designated speech corpus that are automatically classified using the AAC device.	1 hour
System Usability Scale	Ten-question Likert scale assessment giving a global view of subjective, qualitative assessments of device usability. Participants will rank each question from 1 ("strongly disagree") to 5 ("strongly agree") based on how much they agree with the statement they are reading.	1 hour
Test-Retest Reliability	Repeatability of word and prosody recognition rates obtained when placing and replacing the reusable, wearable sEMG sensor veneer.	1 hour
Intelligibility	The degree to which a speaker's message can be recovered by a listener, as measured via listeners orthographically transcribing words from audio samples.	1 hour
Comprehensibility	The degree to which a listener understands the meaning of a speaker's message (e.g., if the phrase is "Jane loves Bob," the listener may be asked to respond to "Who loves Bob?").	1 hour
Device Comfort	Perceived assessment of user comfort when wearing the MyoVoice device as captured via a Likert scale ranked from 1 ("not at all comfortable") to 5 ("very comfortable").	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 (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 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): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Disease; 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 data for all primary and secondary outcome measures 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