Aerodynamic Measurements in the Pediatric Population
Part of paid clinical trials in Iowa City, Iowa.
- Sponsor
- University of Wisconsin, Madison
- Study ID
- NCT06975046
- Status
- Recruiting
Conditions
- Normal Voice
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Complete airflow interruption — DEVICEParticipants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
- Incomplete airflow interruption — DEVICEIncomplete 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.
- Airflow redirection — DEVICEParticipant 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.
Study Details
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.
Key Dates
- Start date
- Dec 22, 2025
- Status verified
- May 2026
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 365 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Complete airflow interruption
- Experimental: Incomplete airflow interruption
- Experimental: Airflow redirection
Primary Outcome Measure
Compare subglottic pressure across different airflow interruption methods [ Time Frame: 60 minutes ]
Central Contacts
- Jack Jiang, MD608-265-7888
- Owen Wischhoff
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | Matt Hoffman Matthew Hoffman, MD (SUB_INVESTIGATOR) |
| University of Wisconsin - Madison | Madison | Wisconsin | 53705 | Jack Jiang, MD Jack Jiang, MD (PRINCIPAL_INVESTIGATOR) |