Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03980275

Enrollment

Registered

2019-06-10

Start date

2019-12-10

Completion date

2030-12-31

Last updated

2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Vocal Cord Paralysis

Keywords

Bilateral vocal fold paralysis, Tracheostomy dependency, Glottic airway obstruction, Stridor

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTBabak Sadoughi, MD

bas9049@med.cornell.edu646-962-4712

PRINCIPAL_INVESTIGATORBabak Sadoughi, MD

Weill Medical College of Cornell University

Outcome results