Back to resultsMyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
Primary Purpose
Rehabilitation of Speech and Language Disorders, Speech Disorders, Speech, Alaryngeal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyoVoice
Electrolarynx
Sponsored by
About this trial
This is an interventional other trial for Rehabilitation of Speech and Language Disorders
Eligibility Criteria
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)
Sites / Locations
- Altec Inc.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MyoVoice Device
Arm Description
MyoVoice Device for individuals with total laryngectomy
Outcomes
Primary Outcome Measures
Word Recognition Rate
Accuracy of identifying individual words from a designated speech corpus that are automatically transcribed using the AAC device.
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.
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.
Test-Retest Reliability
Repeatability of word and prosody recognition rates obtained when placing and replacing the reusable, wearable sEMG sensor veneer.
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.
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?").
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").
Secondary Outcome Measures
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.
Acceptability
The degree to which naïve listeners find a speech sample to be "acceptable" relative to attributes of pitch, rate, understandability and voice quality.
Acoustic Identity
The accuracy in which naïve listeners select which voice sample best matches that of a presented speech sample.
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."
Prosodic sEMG-Acoustic Correlation
Correlation between recognized (sEMG) and ground-truth (acoustic) prosodic tone and break indices (ToBI) measured during speaking tasks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04762043
Brief Title
MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
Official Title
EMG Voice Restoration
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altec Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation of Speech and Language Disorders, Speech Disorders, Speech, Alaryngeal, Communication Aids for Disabled, Speech Perception, Speech Intelligibility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MyoVoice Device
Arm Type
Experimental
Arm Description
MyoVoice Device for individuals with total laryngectomy
Intervention Type
Device
Intervention Name(s)
MyoVoice
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Electrolarynx
Intervention Description
Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
Primary Outcome Measure Information:
Title
Word Recognition Rate
Description
Accuracy of identifying individual words from a designated speech corpus that are automatically transcribed using the AAC device.
Time Frame
1 hour
Title
Prosody Recognition Rate
Description
Accuracy of identifying prosodic tone and break index (ToBI) categories from a designated speech corpus that are automatically classified using the AAC device.
Time Frame
1 hour
Title
System Usability Scale
Description
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.
Time Frame
1 hour
Title
Test-Retest Reliability
Description
Repeatability of word and prosody recognition rates obtained when placing and replacing the reusable, wearable sEMG sensor veneer.
Time Frame
1 hour
Title
Intelligibility
Description
The degree to which a speaker's message can be recovered by a listener, as measured via listeners orthographically transcribing words from audio samples.
Time Frame
1 hour
Title
Comprehensibility
Description
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?").
Time Frame
1 hour
Title
Device Comfort
Description
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").
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
MyoVoice Translation Speed
Description
Duration in which the MyoVoice system carries out sEMG-to-speech synthesis relative to the length and content of the message being synthesized.
Time Frame
1 hour
Title
Acceptability
Description
The degree to which naïve listeners find a speech sample to be "acceptable" relative to attributes of pitch, rate, understandability and voice quality.
Time Frame
1 hour
Title
Acoustic Identity
Description
The accuracy in which naïve listeners select which voice sample best matches that of a presented speech sample.
Time Frame
1 hour
Title
Emotional Content
Description
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."
Time Frame
1 hour
Title
Prosodic sEMG-Acoustic Correlation
Description
Correlation between recognized (sEMG) and ground-truth (acoustic) prosodic tone and break indices (ToBI) measured during speaking tasks.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer M Vojtech, PhD
Phone
5085458208
Email
jvojtech@altecresearch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Serge H Roy
Phone
5085458235
Email
sroy@delsys.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianluca DeLuca
Organizational Affiliation
Altec Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altec Inc.
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer M Vojtech, PhD
Phone
508-545-8208
Email
jvojtech@altecresearch.com
First Name & Middle Initial & Last Name & Degree
Serge H Roy
Phone
5085458235
Email
sroy@delsys.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
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