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Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

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ClinicalTrials.gov Identifier: NCT03980275
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.

Condition or disease
Bilateral Vocal Cord Paralysis

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with bilateral vocal fold paralysis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980275


Contacts
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Contact: Katerina Andreadis 646-962-9883 kaa2055@med.cornell.edu
Contact: Babak Sadoughi, MD 646-962-4712 bas9049@med.cornell.edu

Locations
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United States, New York
Sean Parker Institute for the Voice Recruiting
New York, New York, United States, 10022
Contact: Katerina Andreadis    646-962-9883    kaa2055@med.cornell.edu   
Principal Investigator: Babak Sadoughi, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Babak Sadoughi, MD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03980275     History of Changes
Other Study ID Numbers: 1806019347
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Bilateral vocal fold paralysis
Tracheostomy dependency
Glottic airway obstruction
Stridor
Additional relevant MeSH terms:
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Vocal Cord Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases