DysphoniaNCT05479643
A Personalized Voice Restoration Device for Patients With Laryngectomy
A study testing Surface Electromyography in people with Dysphonia and Aphonia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- What is being tested?
- Surface Electromyography
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2027to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Group A: Healthy Volunteers
- 1. Voice impairment
- Group B: Subjects with Aphonia or Dysphonia
- 1. Subjects whose face muscles are entirely paralyzed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine
New York, New York, 10022
Anaïs Rameau, MD, 646-962-7464, anr2783@med.cornell.edu
Anaïs Rameau, MD
About this study
Official title: A Pilot Study for a Novel and Personalized Voice Restoration Device for Patients With Laryngectomy
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.
Read the 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.
- Being tested
- Surface Electromyography
- Medical subject headings
- Dysphonia, Aphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface ElectromyographyDevice
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 group | Role | What they receive |
|---|---|---|
| Patients with Aphonia or Dysphonia | Experimental | Participants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles. Receives: Device: Surface Electromyography |
| Healthy Volunteers | Placebo comparator | Healthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles. Receives: Device: Surface Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "During Procedure/use of Surface ElectroMyoGraphy"
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.
Measured: 10 minutes after the time of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Dec 2027 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anaïs Rameau, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479643
- Sponsor's protocol ID
- 22-03024627
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for a Novel and Personalized Voice Restoration Device for Patients With Laryngectomy
- ClinicalTrials.gov ID
- NCT05479643
- Acronym / sponsor ID
- 22-03024627
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Aphonia or Dysphonia | Experimental | Device: Surface ElectromyographyParticipants with Aphonia or Dysphonia will be asked to recite phrases with sEMG attached to articulatory muscles. |
| Healthy Volunteers | Placebo comparator | Device: Surface ElectromyographyHealthy Volunteer will be asked to recite phrases with sEMG attached to articulatory muscles. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Group A: Healthy Volunteers
- 1. Voice impairment
- Group B: Subjects with Aphonia or Dysphonia
- 1. Subjects whose face muscles are entirely paralyzed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface ElectromyographySurface 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. | Device | Healthy Volunteers, Patients with Aphonia or Dysphonia |
Primary outcome
Percentage of Words and Numbers Correctly Identified
Time frame: "During Procedure/use of Surface ElectroMyoGraphy"
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.
Subject experience with voice restoration devices: Qualitative
Time frame: 10 minutes after the time of intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Dysphonia
Not yet recruiting
EMG-Guided Versus Endoscopic-Catheter Botulinum Toxin Injection for Spasmodic Dysphonia
Spasmodic Dysphonia
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Not yet recruitingObservational study
Irrigation Fluid Volume, Tube Cuff Pressure, and Neck Swelling During Shoulder Arthroscopy
Shoulder Arthroscopy, Endotracheal Tube Cuff Pressure
Not yet recruitingObservational study
Effects of Video LMA Cuff Pressure in Tympanoplasty.
Oropharyngeal Leak Pressure, Airway Management
Recruiting
Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery
Hoarseness, Post Operative Complicaiton
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anaïs Rameau, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface Electromyography in people with Dysphonia and Aphonia, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anaïs Rameau, MD (646-962-7464, anr2783@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Words and Numbers Correctly Identified (time frame: "During Procedure/use of Surface ElectroMyoGraphy"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.