Bilateral Vocal Cord ParalysisNCT03980275
Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis
An observational study of Bilateral Vocal Cord Paralysis, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bilateral Vocal Cord Paralysis
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 31 Dec 2030
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with bilateral vocal fold paralysis
Who may be able to join
- Patients aged 18-70
- Patients with bilateral vocal fold paralysis without any improvement for 6 months
Who cannot join
- Patients with neck or chest radiation
- Patients with severe respiratory compromise
- Patients with cricoarytenoid ankylosis
- Patients with pacemakers
- Patients who are pregnant
- Patients with cochlear implant, or any nerve stimulator implants
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, 1 recruiting
- Recruiting
Sean Parker Institute for the Voice
New York, New York, 10022
Babak Sadoughi, MD, bas9049@med.cornell.edu
Babak Sadoughi, MD
About this study
This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.
- Conditions
- Bilateral Vocal Cord Paralysis
- Keywords
- Bilateral vocal fold paralysis, Tracheostomy dependency, Glottic airway obstruction, Stridor
- Medical subject headings
- Respiratory Sounds
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breathing function is being assessed and measured by the Dyspnea Index (DI)
The DI is a standardized and validated tool to quantify patients' symptoms of upper airway dyspnea. It's a 10-item questionnaire. The lowest score is 0, which indicates that the patient is never experiencing dyspnea symptoms, and the highest is 40, which indicates that the patient is always experiencing dyspnea symptoms.
Measured: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months
Change in breathing function is being assessed and measured by pulmonary function testing
Pulmonary function testing will measure the total inspiratory and expiratory tidal volumes.
Measured: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start10 Dec 2019
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Vocal Cord ParalysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Babak Sadoughi, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980275
- Sponsor's protocol ID
- 1806019347
- Status last verified
- Apr 2026
- First submitted
- 4 Jun 2019
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis
- ClinicalTrials.gov ID
- NCT03980275
- Acronym / sponsor ID
- 1806019347
- Conditions
- Bilateral Vocal Cord Paralysis
- Keywords
- Bilateral vocal fold paralysis, Tracheostomy dependency, Glottic airway obstruction, Stridor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Jun 2019 (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.
This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with bilateral vocal fold paralysis
Key inclusion criteria (2 listed)
- Patients aged 18-70
- Patients with bilateral vocal fold paralysis without any improvement for 6 months
Key exclusion criteria (6 listed)
- Patients with neck or chest radiation
- Patients with severe respiratory compromise
- Patients with cricoarytenoid ankylosis
- Patients with pacemakers
- Patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in breathing function is being assessed and measured by the Dyspnea Index (DI)
Time frame: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months
The DI is a standardized and validated tool to quantify patients' symptoms of upper airway dyspnea. It's a 10-item questionnaire. The lowest score is 0, which indicates that the patient is never experiencing dyspnea symptoms, and the highest is 40, which indicates that the patient is always experiencing dyspnea symptoms.
Change in breathing function is being assessed and measured by pulmonary function testing
Time frame: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months
Pulmonary function testing will measure the total inspiratory and expiratory tidal volumes.
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 21 Apr 2026.
Related trials for Bilateral Vocal Cord Paralysis
Active, not recruiting
Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx
Bilateral Vocal Fold Paralysis (BVFP)
Active, not recruiting
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
Bilateral Vocal Cord Paralysis
Not yet recruiting
Peri-operative BiPAP to Prevent Tracheostomy in High-Risk Bilateral Vocal-Cord Paralysis (BVCP)
Vocal Cord Paralysis, Bilateral, Airway Obstruction, Postoperative
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.
Babak Sadoughi, 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?
An observational study of Bilateral Vocal Cord Paralysis, 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Apr 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. 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 Babak Sadoughi, MD (646-962-4712, bas9049@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breathing function is being assessed and measured by the Dyspnea Index (DI) (time frame: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months). 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 21 Apr 2026.