N/A
N=30
MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
Rehabilitation of Speech and Language Disorders · Speech Disorders · Speech, Alaryngeal · Communication Aids for Disabled · Speech Perception
Bottom Line
View on ClinicalTrials.gov: NCT04762043 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Pitch Recognition Accuracy — 7.70 Percent agreement to reference pitch
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental System: MyoVoice (Device); Reference System: Electrolarynx (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Altec Inc.
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pitch Recognition Accuracy |
7.70 | — |
| PRIMARY Loudness Recognition Accuracy |
12.1 | — |
| PRIMARY Speech Naturalness |
66.2; 9.7; 38.0 | <.001 sig |
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.
Eligibility Criteria
- Individuals without Laryngectomy ("Controls")
Inclusion Criteria
- 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 Criteria
- 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
Exclusion Criteria
- 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)
- Inability to provide written informed consent
Data sourced from ClinicalTrials.gov (NCT04762043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.