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

NCT04762043 | Completed Results

• 1 other identifier: EMG Voice Restoration
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation of Speech and Language Disorders; Speech Disorders; Speech, Alaryngeal; Communication Aids for Disabled; Speech Perception; Speech Intelligibility

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental and Reference Devices for Communication

EXPERIMENTAL

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; Device: Reference System: Electrolarynx

Development of Speech Corpora

NO INTERVENTION

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.

Interventions

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.

Experimental and Reference Devices for Communication

Reference System: Electrolarynx DEVICE

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

Experimental and Reference Devices for Communication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Altec Inc.: lead

Study Sites (1)

Altec Inc.

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Language Disorders; Speech Disorders; Speech; Speech Intelligibility

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior

Results Point of Contact

• Title: Dr. Joshua Kline
• Organization: Altec, Inc.

jkline@altecresearch.com

5085458212

Study Officials

• Gianluca DeLuca

  Altec Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: February 12, 2021
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available within 6 months of study completion.
• Access Criteria: Data access request will be made through conferencing.

Locations

US (1)