Rehabilitation of Speech and Language DisordersNCT04762043
MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
A study testing Experimental System: MyoVoice and Reference System: Electrolarynx in people with Rehabilitation of Speech and Language Disorders and Speech Disorders, run by Altec Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation of Speech and Language Disorders, Speech Disorders, Speech, Alaryngeal
- What is being tested?
- Experimental System: MyoVoice and Reference System: Electrolarynx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 8 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- At least 6 months S/P total laryngectomy
- Primary English speaker
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- Proficient with an electrolarynx (EL)
- Sufficiently available and healthy to comply with multiple test sessions lasting 4-6 hours
- Capable of signed informed consent
Who cannot join
- 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
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EMG Voice Restoration
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.
Read the 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.
- Conditions
- Rehabilitation of Speech and Language Disorders, Speech Disorders, Speech, Alaryngeal, Communication Aids for Disabled, Speech Perception, Speech Intelligibility
- Being tested
- Experimental System: MyoVoice, Reference System: Electrolarynx
- Medical subject headings
- Language Disorders, Speech Disorders, Speech, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental System: MyoVoiceDevice
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: ElectrolarynxDevice
Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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%.
Measured: 30 mins to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start12 Feb 2021
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rehabilitation of Speech and Language DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianluca DeLuca, Principal investigator, Altec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762043
- Sponsor's protocol ID
- EMG Voice Restoration
- Status last verified
- May 2024
- First submitted
- 17 Feb 2021
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant demographics, summary data for all primary and secondary outcome measures, and study protocol will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG Voice Restoration
- ClinicalTrials.gov ID
- NCT04762043
- Acronym / sponsor ID
- EMG Voice Restoration
- Conditions
- Rehabilitation of Speech and Language Disorders, Speech Disorders, Speech, Alaryngeal, Communication Aids for Disabled, Speech Perception, Speech Intelligibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Altec Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental and Reference Devices for Communication | Experimental | Device: Experimental System: MyoVoice, Device: Reference System: ElectrolarynxEach 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- Individuals with Laryngectomy
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental System: MyoVoicePerson-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. | Device | Experimental and Reference Devices for Communication |
| Reference System: ElectrolarynxHand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech. | Device | Experimental and Reference Devices for Communication |
Primary outcome
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%.
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%.
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%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant demographics, summary data for all primary and secondary outcome measures, and study protocol will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca DeLuca principal investigator
Altec Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental System: MyoVoice and Reference System: Electrolarynx in people with Rehabilitation of Speech and Language Disorders and Speech Disorders, run by Altec Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pitch Recognition Accuracy (time frame: 30 mins to 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.