A Personalized Voice Restoration Device for Patients With Laryngectomy

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05479643
Status
Not Yet Recruiting

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Conditions

  • Aphonia
  • Dysphonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 1, 2027
Status verified
Dec 2025
Primary completion
Dec 1, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Patients with Aphonia or Dysphonia
    Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles.
  • Placebo Comparator: Healthy Volunteers
    Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles.

Primary Outcome Measure

Percentage of Words and Numbers Correctly Identified [ Time Frame: "During Procedure/use of Surface ElectroMyoGraphy" ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10022
Anaïs Rameau, MD
[email protected]
646-962-7464
Anaïs Rameau, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine· New York, NY

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