Status:
COMPLETED
MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
Lead Sponsor:
Altec Inc.
Conditions:
Rehabilitation of Speech and Language Disorders
Speech Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
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 record...
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 te...
Eligibility Criteria
Inclusion
- Individuals without Laryngectomy ("Controls")
- 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
Exclusion
- 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
- Inclusion Criteria:
- 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 Trial Info
Start Date :
February 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04762043
Start Date
February 12 2021
End Date
November 8 2023
Last Update
September 23 2024
Active Locations (1)
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1
Altec Inc.
Natick, Massachusetts, United States, 01760