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Status:

WITHDRAWN

Modeling the Effects of Vocal Cord Atrophy on Airflow and Voice Quality in Elderly Individuals

Lead Sponsor:

Duke University

Conditions:

Vocal Cord Atrophy

Eligibility:

All Genders

65-80 years

Phase:

NA

Brief Summary

1. The purpose of this study is to develop a validated computational model for assessing normative change in these patterns in patients with vocal cord atrophy before and after voice therapy. 2. This ...

Eligibility Criteria

Inclusion

  • Healthy Subjects Cohort:
  • Inclusion criteria:
  • Between 65 and 80 years of age
  • Voice Handicap Index (VHI) questionnaire score of less than 10.
  • Little or no dysphonia as assessed by a speech language pathologist from the Duke Voice Care Center
  • No contraindications to have a CBCT scan (as assessed per standard clinical practice)
  • Exclusion criteria:
  • Inability to speak, read, write, and understand English
  • Inability to provide written consent
  • Self-reported or known allergy to Afrin or Tetracaine HCL (or related class of drugs) and unable or willing to complete the laryngovideostroboscopy procedure with it.
  • Vocal Cord Atrophy Cohort:
  • Inclusion criteria:
  • Between 65 and 80 years of age
  • Clinical diagnosis of vocal cord atrophy (VCA)
  • Treated for the above condition by a provider at the Duke Head and Neck Surgery \& Communication Sciences Clinic
  • Elected to undergo voice therapy as standard of care for treatment of VCA
  • Exclusion criteria:
  • Other conditions that affect the voice and would interfere with study measures, as determined by PI
  • Inability to speak, read, write, and understand English
  • Inability to provide written consent
  • Self-reported or known allergy to Afrin or Tetracaine HCL (or related class of drugs) and unable or willing to complete the laryngovideostroboscopy procedure with it.

Exclusion

    Key Trial Info

    Start Date :

    March 28 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2020

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT03458104

    Start Date

    March 28 2018

    End Date

    September 1 2020

    Last Update

    April 7 2020

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Duke University Medical Center

    Durham, North Carolina, United States, 27710