Recruiting

Vocal Health Database

Sponsor:

University of Wisconsin, Madison

Code:

NCT06975046

Conditions

Normal Voice

Eligibility Criteria

Sex: All

Age: 4 - 65

Healthy Volunteers: Accepted

Interventions

Complete airflow interruption

Incomplete airflow interruption

Airflow redirection

Study Details

Brief 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.

Conditions

Normal Voice

Study ID

NCT06975046

Start date

Dec 22, 2025

Status verified date

May, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 65

Healthy Volunteers: Accepted

Inclusion Criteria - Healthy Control:

  • Age 4-65 years
  • Normal voice
  • No history of voice or other pertinent health disorders

Exclusion Criteria - Healthy Control:

  • Neuromuscular disorder affecting the larynx
  • History of respiratory or laryngeal disease
  • History of smoking
  • Hearing impairment
  • Cognitive impairment that might impact ability to perform the tasks required by the study

Inclusion Criteria - Abnormal Voice:

  • Age 4-17
  • Laryngeal pathology

Exclusion Criteria - Abnormal Voice:

  • No laryngeal disorder

Study Design

Enrollment

365 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Complete airflow interruption

experimental: Incomplete airflow interruption

experimental: Airflow redirection

Interventions

Complete airflow interruption

Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve

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.

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.

Primary outcome measure

  • Compare subglottic pressure across different airflow interruption methods [ Time Frame: 60 minutes ]
  • Compare phonation threshold pressure (PTP) across airflow interruption methods [ Time Frame: 60 minutes ]
  • Compare laryngeal resistance across airflow interruption methods [ Time Frame: 90 minutes ]
  • Compare subglottic pressure between benign vocal fold lesions and normal voices [ Time Frame: 90 minutes ]
  • Compare PTP between benign vocal fold lesions and normal voices [ Time Frame: 90 minutes ]
  • Compare laryngeal resistance between benign vocal fold lesions and normal voices [ Time Frame: 90 minutes ]
  • Compare vocal efficiency between benign vocal fold lesions and normal voices [ Time Frame: 90 minutes ]
  • Compare mean airflow rate between benign vocal fold lesions and normal voices [ Time Frame: 90 minutes ]

Central Contacts and Locations

Central contacts

Jack Jiang, MD

608-265-7888jjjiang@wisc.edu

Owen Wischhoff

owischhoff@wisc.edu

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Jack Jiang, MD

jjjiang@wisc.edu

Principal Investigator:

Jack Jiang, MD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-15.