An interventional study of Experimental System: MyoVoice and Reference System: Electrolarynx in Rehabilitation of Speech and Language Disorders, Speech Disorders and Speech, Alaryngeal, sponsored by Altec Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Altec Inc. · Not applicable, Interventional, and Other
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.
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.
77 studies on the registry are indexed under Speech Disorders; 20 are open to participants now.
This study's enrollment of 30 is below the median of 38 across 54 interventional studies indexed under Speech Disorders.
Browse Speech Disorders studies →Altec Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Compared within Speech Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Language Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Individuals without Laryngectomy ("Controls")
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 30 mins to 1 hour
| Milestone | Development of Speech Corpora | Experimental and Reference Devices for Communication |
|---|---|---|
| Started | 10 | 20 |
| Completed | 10 | 20 |
| Not completed | 0 | 0 |
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%.
| Percent agreement to reference pitch | Development of Speech Corpora | Experimental and Reference Devices for Communication |
|---|---|---|
| Pitch Recognition Accuracy | 7.70 ± 1.63 | — |
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%.
| Percent agreement to reference loudness | Development of Speech Corpora | Experimental and Reference Devices for Communication |
|---|---|---|
| Loudness Recognition Accuracy | 12.1 ± 3.0 | — |
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%.
| Percent of high naturalness ratings | Development of Speech Corpora | Experimental and Reference Devices for Communication |
|---|---|---|
| MyoVoice | — | 66.2 ± 22.6 |
| Electrolarynx | — | 9.7 ± 19.8 |
| Overall | — | 38.0 ± 35.4 |
Collected over 30 min - 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Development of Speech Corpora | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Experimental and Reference Devices for Communication | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Development of Speech Corpora | Experimental and Reference Devices for Communication | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 18 | 28 |
| >=65 years | 0 | 2 | 2 |
| Age, Continuous(years) | Development of Speech Corpora | Experimental and Reference Devices for Communication | Total |
|---|---|---|---|
| Mean | 28 ± 7.65 | 55 ± 7.30 | 42 ± 15.58 |
| Sex: Female, Male(Participants) | Development of Speech Corpora | Experimental and Reference Devices for Communication | Total |
|---|---|---|---|
| Female | 5 | 9 | 14 |
| Male | 5 | 11 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Development of Speech Corpora | Experimental and Reference Devices for Communication | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 9 | 18 | 27 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Development of Speech Corpora | Experimental and Reference Devices for Communication | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 10 | 17 | 27 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(Participants) | Development of Speech Corpora | Experimental and Reference Devices for Communication | Total |
|---|---|---|---|
| United States | 10 | 20 | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant demographics, summary data for all primary and secondary outcome measures, and study protocol will be made available.
Supporting information: 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.
Ran from Feb 2021 to primary completion in Nov 2023, 32 months.
Results were first posted in Sep 2024, 10 months after primary completion.
Of 37 interventional studies with no phase under Speech Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 38. This study's 32 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Altec Inc.