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Completed

NCT Number: NCT04762043

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Treatment and study plan

Experimental System: MyoVoice

Device

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.

Reference System: Electrolarynx

Device

Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.

Primary outcomes

  1. Pitch Recognition Accuracy

    Time frame: 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%.

  2. Loudness Recognition Accuracy

    Time frame: 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%.

  3. Speech Naturalness

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

Altec Inc.

Industry

Registry information

Official study title

EMG Voice Restoration

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2021
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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