Clinical trial NCT04762043: MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
Official title: EMG Voice Restoration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation of Speech and Language Disorders
Speech Disorders
Speech, Alaryngeal
Communication Aids for Disabled
Speech Perception
Speech Intelligibility
Lead sponsor: Altec Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Pitch Recognition Accuracy
timeFrame: 30 mins to 2 hours
measure: Loudness Recognition Accuracy
timeFrame: 30 mins to 2 hours
measure: Speech Naturalness
timeFrame: 30 mins to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Natick
country: United States
facility: Altec Inc.
state: Massachusetts
Study officials:
affiliation: Altec Inc.
name: Gianluca DeLuca
role: PRINCIPAL_INVESTIGATOR
References: