Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762043
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2021-02-17
Brief Title:
MyoVoice to Restore Natural Hands-free Communication to Individuals With Vocal Impairments
Sponsor:
Altec Inc
Organization:
Altec Inc
Study Overview
Official Title:
EMG Voice Restoration
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 75 million people worldwide are unable to vocalize effectively Among these individuals are cancer survivors who underwent oropharyngeallaryngeal 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 ie artificial larynx to evaluate device ease-of-use functional efficacy and social reception
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None