A Personalized Voice Restoration Device for Patients With Laryngectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surface Electromyography.
- Who it may be relevant to
- Registry conditions: Dysphonia, Aphonia. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study for a Novel and Personalized Voice Restoration Device for Patients With Laryngectomy
Overview
The investigators will conduct a pilot experiment for a novel and personalized method for voice restoration using machine learning applied to surface EMG (sEMG) signal from articulatory muscles of the face and the neck allowing recognition of silent speech. The investigators predict that the use novel personalized method for voice restoration will be feasible and successful for patients.
Detailed description
This is a prospective pilot study evaluating the feasibility of a personalized voice restoration device and patients' experience with it. Study participation will include a one-time visit where subjects will read passages and phrases. Acoustic and signal data will be captured. Machine learning will be applied to the data to classify words. Subjects will also participate in a qualitative interview about their experience with voice restoration devices.
Interventions
- Device Surface Electromyography
Surface ElectroMyoGraphy (SEMG) is a non-invasive technique for measuring muscle electrical activity that occurs during muscle contraction and relaxation cycles. Electrodes will be attached with a AgCl gel to muscles used for articulation.
Primary outcome measures
- Percentage of Words and Numbers Correctly Identified [Time frame: "During Procedure/use of Surface ElectroMyoGraphy"]
- Subject experience with voice restoration devices: Qualitative [Time frame: 10 minutes after the time of intervention]
Eligibility criteria
Inclusion criteria
Group A: Healthy Volunteers
- Adult subjects, 18 or older
- Without any voice impairments
Group B: Subjects with Aphonia or Dysphonia
- Adult subjects, 18 or older
- Documentation of severe dysphonia and/or aphonia, or a GRBAS score > 0 (GRBAS is a scale that can be used to assess voice quality of subjects who do not have a recorded history of dysphonia or aphonia. The GRBAS scale evaluates for grade, roughness, breathiness, asthenia, and strain).
Exclusion criteria
\- Group A: Healthy Volunteers
1\. Voice impairment
Group B: Subjects with Aphonia or Dysphonia
1\. Subjects whose face muscles are entirely paralyzed
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT05479643 · 22-03024627