Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

July 25, 2023 updated by: Weill Medical College of Cornell University
This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10022
        • Recruiting
        • Sean Parker Institute for the Voice
        • Contact:
        • Principal Investigator:
          • Babak Sadoughi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with bilateral vocal fold paralysis

Description

Inclusion Criteria:

  • Patients aged 18-70
  • Patients with bilateral vocal fold paralysis without any improvement for 6 months

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Babak Sadoughi, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1806019347

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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