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 — DEVICE
    Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
  • Incomplete airflow interruption — DEVICE
    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.
  • Airflow redirection — DEVICE
    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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Matt Hoffman
Matthew Hoffman, MD (SUB_INVESTIGATOR)
University of Wisconsin - MadisonMadisonWisconsin53705
Jack Jiang, MD
Jack Jiang, MD (PRINCIPAL_INVESTIGATOR)

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