NCT03980275

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
57mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Dec 2019Dec 2030

First Submitted

Initial submission to the registry

June 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

11.1 years

First QC Date

June 4, 2019

Last Update Submit

April 20, 2026

Conditions

Bilateral Vocal Cord Paralysis

Keywords

Bilateral vocal fold paralysisTracheostomy dependencyGlottic airway obstructionStridor

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with bilateral vocal fold paralysis

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sean Parker Institute for the Voice

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Babak Sadoughi, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Babak Sadoughi, MD

CONTACT

646-962-4712bas9049@med.cornell.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 10, 2019

Study Start

December 10, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

US(1)