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NCT Number: NCT03980275

Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

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

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Key information

Conditions

Bilateral Vocal Cord Paralysis Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sean Parker Institute for the Voice

New York, 10022, United States

Location status: Recruiting

Location contact

Babak Sadoughi, MD

CONTACT

[email protected]

Babak Sadoughi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Babak Sadoughi, MD

CONTACT

[email protected]

646-962-4712

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jun 10, 2019
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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