NCT06975046

Aerodynamic Measurements in the Pediatric Population

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 365 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to create a vocal health database of people aged 4-65 with no diagnosed voice pathology. The main question it aims to answer is: * what is the best way to assess pediatric voices; and, * what are the differences between healthy and dysphonic pediatric voices? Participants will complete one 60 minute session involving one of three types of aerodynamic interruption.

Detailed description

The primary goals of this research are to develop noninvasive aerodynamic assessments specific to the pediatric population, and to describe differences between healthy and dysphonic pediatric voices between the ages of 4-17 years. An adult cohort (ages 18-65) will function as a comparison group for incomplete interruption. To account for challenges associated with pediatric data collection, we will modify our current devices and methods of aerodynamic assessment to be better suited for use with the pediatric population and aim to increase measurement reliability in younger subjects. Our proposed modifications include shorter trial times, auditory masking, the use of cheek restraints, and gamification. After identification of optimal data collection conditions for each method, we will compare these in a large group of children with normal voice. These data will be compared to data from children with vocal fold nodules or polyp. All data will be compiled into a pediatric vocal health database.

Conditions

• Normal Voice

Interventions

Type	Name	Description
DEVICE	Complete airflow interruption	Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
DEVICE	Incomplete airflow interruption	Incomplete airflow interruption uses a Y-shaped device. The participant produces a sustained /a/ into a mouthpiece and air filter connected to the tube. The tube splits into two tubes distally.
DEVICE	Airflow redirection	Participant phonates through a mouthpiece into a PVC tube that splits into two paths. One path is connected to an open balloon valve. When the balloon is inflated and blocks the path, air is redirected into the other path which is gated by a one-way valve.

Timeline

• Start date: 2025-12-22
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-05-16
• Last updated: 2026-04-16

Locations

2 sites across 1 country: United States