Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT03458104
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
80 Years
Study:
NCT03458104
Study Brief:
Protocol Section:
NCT03458104