A Personalized Voice Restoration Device for Patients With Laryngectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-110
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult subjects, 18 or older

Without any voice impairments

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).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surface Electromyography

    Device

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Patients with Aphonia or DysphoniaExperimental treatment 1 intervention
Group B: Healthy VolunteersPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Words and Numbers Correctly Identified

Accuracy of sEMG signal will be determined by subjects reciting common phrases. Subjects will recite the "Rainbow Passage" 10 times. Subjects will be asked to count from 1-10 once. Subjects will recite the alphabet once.

Time frame
"During Procedure/use of Surface ElectroMyoGraphy"
2

Subject experience with voice restoration devices: Qualitative

Subject will be asked to complete a semi-structured interview about their experience with voice restoration devices. Categories of response include voice/communication history, experience with previous voice restoration devices, experience with our device, and suggestions for improvement.

Time frame
10 minutes after the time of intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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