NCT03458104

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vocal Cord Atrophy

Interventions

Type	Name	Description
OTHER	Cone Beam Computed Tomography	Cone Beam CT of the larynx
DIAGNOSTIC_TEST	Acoustic/Auerodynamic testing	Records and displays real-time sound pressure level intensity, intraoral pressure, airflow rate, and fundamental frequency
DIAGNOSTIC_TEST	Laryngovideostroboscopy	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.

Timeline

• Start date: 2018-03-28
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2018-03-08
• Last updated: 2020-04-07

Locations

1 site across 1 country: United States