Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis
Recruiting
- Conditions
- Bilateral Vocal Cord Paralysis
- Registration Number
- NCT03980275
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in breathing function is being assessed and measured by the Dyspnea Index (DI) 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sean Parker Institute for the Voice
🇺🇸New York, New York, United States