Trial Outcomes & Findings for MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments (NCT NCT04762043)
NCT ID: NCT04762043
Last Updated: 2024-09-23
Results Overview
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%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
30 mins to 2 hours
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
Development of Speech Corpora
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.
|
Experimental and Reference Devices for Communication
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.
Experimental System: MyoVoice: 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: Electrolarynx: Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
20
|
|
Overall Study
COMPLETED
|
10
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
Baseline characteristics by cohort
| Measure |
Development of Speech Corpora
n=10 Participants
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.
|
Experimental and Reference Devices for Communication
n=20 Participants
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.
Experimental System: MyoVoice: 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.
Reference System: Electrolarynx: Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 7.65 • n=99 Participants
|
55 years
STANDARD_DEVIATION 7.30 • n=107 Participants
|
42 years
STANDARD_DEVIATION 15.58 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 mins to 2 hoursPopulation: The sEMG and acoustic data collected from participants in the "Development of Speech Corpora" arm were used to develop and evaluate an algorithm to predict vocal pitch (acoustic correlate: fundamental frequency) from sEMG data. Higher accuracy scores equate to better performance.
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%.
Outcome measures
| Measure |
Development of Speech Corpora
n=10 Participants
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.
|
Experimental and Reference Devices for Communication
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.
Experimental System: MyoVoice: 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.
Reference System: Electrolarynx: Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
|
|---|---|---|
|
Pitch Recognition Accuracy
|
7.70 Percent agreement to reference pitch
Standard Deviation 1.63
|
—
|
PRIMARY outcome
Timeframe: 30 mins to 2 hoursPopulation: The sEMG and acoustic data collected from participants in the "Development of Speech Corpora" arm were used to develop and evaluate an algorithm to predict vocal loudness (acoustic correlate: intensity) from sEMG data. Higher accuracy scores equate to better performance.
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%.
Outcome measures
| Measure |
Development of Speech Corpora
n=10 Participants
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.
|
Experimental and Reference Devices for Communication
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.
Experimental System: MyoVoice: 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.
Reference System: Electrolarynx: Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
|
|---|---|---|
|
Loudness Recognition Accuracy
|
12.1 Percent agreement to reference loudness
Standard Deviation 3.0
|
—
|
PRIMARY outcome
Timeframe: 30 mins to 1 hourPopulation: Participants in the "Experimental and Reference Devices for Communication" rated the naturalness of each sample on a visual analog scale from 0 to 100, which 0 anchored at "least natural" and 100 anchored at "most natural." Higher naturalness scores equate to better performance.
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%.
Outcome measures
| Measure |
Development of Speech Corpora
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.
|
Experimental and Reference Devices for Communication
n=20 Participants
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.
Experimental System: MyoVoice: 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.
Reference System: Electrolarynx: Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
|
|---|---|---|
|
Speech Naturalness
MyoVoice
|
—
|
66.2 Percent of high naturalness ratings
Standard Deviation 22.6
|
|
Speech Naturalness
Electrolarynx
|
—
|
9.7 Percent of high naturalness ratings
Standard Deviation 19.8
|
|
Speech Naturalness
Overall
|
—
|
38.0 Percent of high naturalness ratings
Standard Deviation 35.4
|
Adverse Events
Development of Speech Corpora
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental and Reference Devices for Communication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place