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

Not Applicable

Withdrawn

• Conditions: Vocal Cord Atrophy
• Interventions: Other: Cone Beam Computed Tomography; Diagnostic Test: Acoustic/Auerodynamic testing; Diagnostic Test: Laryngovideostroboscopy

• Registration Number: NCT03458104
• Lead Sponsor: Duke University

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 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.

3. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-08
• Study Start: 2018-03-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vocal Cord Atrophy	Acoustic/Auerodynamic testing	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.
Healthy Volunteer	Cone Beam Computed Tomography	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.
Vocal Cord Atrophy	Cone Beam Computed Tomography	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.
Vocal Cord Atrophy	Laryngovideostroboscopy	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.
Healthy Volunteer	Acoustic/Auerodynamic testing	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.
Healthy Volunteer	Laryngovideostroboscopy	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.

Primary Outcome Measures

Name	Time	Method
Change in acoustic/aerodynamic quantities as measured by the Phonatory Aerodynamic System	Baseline, 12 weeks	Composite score of vital capacity, mean airflow rate, laryngeal airway resistance, maximum phonation duration, sound pressure level, frequency, aerodynamci dfficiency

Secondary Outcome Measures

Name	Time	Method
Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy.	Baseline, 12 weeks	before and after treatment changes of aerodynamic and aeroacoustic patterns

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States