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

Primary Purpose

Vocal Cord Atrophy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cone Beam Computed Tomography
Acoustic/Auerodynamic testing
Laryngovideostroboscopy
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vocal Cord Atrophy

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vocal Cord Atrophy

Healthy Volunteer

Arm Description

Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy. To evaluate changes, subjects will have Laryngovideostroboscopy, Acoustic/Auerodynamic testing, and Cone Beam CT scans of the larynx before and after voice therapy.

Develop a validated computational model for assessing normative laryngeal aerodynamic and aeroacoustic patterns in healthy elderly individuals. To assess normal laryngeal aerodynamic and aeroacoustic patterns in this cohort, subjects will subjects will have Laryngovideostroboscopy, Acoustic/Auerodynamic testing, and Cone Beam CT scans of the larynx.

Outcomes

Primary Outcome Measures

Change in acoustic/aerodynamic quantities as measured by the Phonatory Aerodynamic System
Composite score of vital capacity, mean airflow rate, laryngeal airway resistance, maximum phonation duration, sound pressure level, frequency, aerodynamci dfficiency

Secondary Outcome Measures

Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy.
before and after treatment changes of aerodynamic and aeroacoustic patterns

Full Information

First Posted
February 9, 2018
Last Updated
April 3, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03458104
Brief Title
Modeling the Effects of Vocal Cord Atrophy on Airflow and Voice Quality in Elderly Individuals
Official Title
Modeling the Effects of Vocal Cord Atrophy on Airflow and Voice Quality in Elderly Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment logistics
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. This is a prospective study comparing two cohorts - patients with vocal cord atrophy(VCA) (G1) and healthy controls (G2). Subjects with VCA will receive a cone beam computed tomography (CBCT) scan with the standard laryngeal protocol before and after voice therapy. Healthy controls will also receive one cone beam computed tomography (CBCT) scan. Subjects with VCA (G1) will undergo post-therapy scans approximately 4 weeks after completion of voice therapy treatment. Enrolled subjects will also undergo a video stroboscopy and acoustic/aerodynamic testing. Subjects in G1 typically have these procedures performed before and after voice therapy as standard of care. Participants in G2 (healthy controls) will have the video stroboscopy and acoustic/aerodynamic testing just once since they would not otherwise be scheduled to undergo voice therapy. Potential subjects will be between 65 and 80 years of age will be considered for the study if they qualify based on inclusion criteria. Potential subjects will undergo are pre-screening process involving an initial telephone screening. Raw data (measured and calculated) derived from this pilot study will be reported, and no statistical analysis will be performed. Data from specific aim 1 (G2) and specific aim 2 (G1) will be compared using graphical representations such as bar and dot plots. There is a potential for the loss of confidentiality; however, every reasonable effort will be made to limit breaches of privacy and confidentiality. Subjects may directly benefit from this study. In addition, data and conclusions derived from this study may help future patients regarding the effects of vocal therapy on vocal cord atrophy (VCA). The investigators will recruit up to 12 subjects to account for screen failures. Once 8 eligible subjects are enrolled (4 per group), then enrollment will end.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Atrophy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vocal Cord Atrophy
Arm Type
Experimental
Arm Description
Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy. To evaluate changes, subjects will have Laryngovideostroboscopy, Acoustic/Auerodynamic testing, and Cone Beam CT scans of the larynx before and after voice therapy.
Arm Title
Healthy Volunteer
Arm Type
Active Comparator
Arm Description
Develop a validated computational model for assessing normative laryngeal aerodynamic and aeroacoustic patterns in healthy elderly individuals. To assess normal laryngeal aerodynamic and aeroacoustic patterns in this cohort, subjects will subjects will have Laryngovideostroboscopy, Acoustic/Auerodynamic testing, and Cone Beam CT scans of the larynx.
Intervention Type
Other
Intervention Name(s)
Cone Beam Computed Tomography
Intervention Description
Cone Beam CT of the larynx
Intervention Type
Diagnostic Test
Intervention Name(s)
Acoustic/Auerodynamic testing
Intervention Description
Records and displays real-time sound pressure level intensity, intraoral pressure, airflow rate, and fundamental frequency
Intervention Type
Diagnostic Test
Intervention Name(s)
Laryngovideostroboscopy
Intervention Description
Visualization of vocal cords in slow motion. It uses a stroboscopic lamp, which generates regular flashes of light. A flexible tube is inserted in the back of the mouth or through the nose and into the throat. Video pictures are then recorded while patients are making sound.
Primary Outcome Measure Information:
Title
Change in acoustic/aerodynamic quantities as measured by the Phonatory Aerodynamic System
Description
Composite score of vital capacity, mean airflow rate, laryngeal airway resistance, maximum phonation duration, sound pressure level, frequency, aerodynamci dfficiency
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy.
Description
before and after treatment changes of aerodynamic and aeroacoustic patterns
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Frank-Ito, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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