NCT06975046

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Dec 2025Dec 2030

First Submitted

Initial submission to the registry

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 16, 2026

Status Verified

May 1, 2025

Enrollment Period

4.9 years

First QC Date

May 8, 2025

Last Update Submit

April 13, 2026

Conditions

Normal Voice

Outcome Measures

Primary Outcomes (8)

  • Compare subglottic pressure across different airflow interruption methods

    Subglottic pressure is measured in kPa of leakage of air between the vocal folds and the resistance to that flow during speech

    60 minutes

  • Compare phonation threshold pressure (PTP) across airflow interruption methods

    PTP is is calculated by subtracting the intraoral pressure at phonation cessation from the subglottal pressure (Ps).

    60 minutes

  • Compare laryngeal resistance across airflow interruption methods

    Pressure and airflow measurements can be taken and entered into equations (Ps = (LR) U1+ Z1U1 and Ps = (LR)U2+Z2U2) to calculate Laryngeal resistance and Ps.

    90 minutes

  • Compare subglottic pressure between benign vocal fold lesions and normal voices

    Subglottic pressure is measured in kPa of leakage of air between the vocal folds and the resistance to that flow during speech

    90 minutes

  • Compare PTP between benign vocal fold lesions and normal voices

    PTP is is calculated by subtracting the intraoral pressure at phonation cessation from the subglottal pressure (Ps).

    90 minutes

  • Compare laryngeal resistance between benign vocal fold lesions and normal voices

    Pressure and airflow measurements can be taken and entered into equations (Ps = (LR) U1+ Z1U1 and Ps = (LR)U2+Z2U2) to calculate Laryngeal resistance and Ps.

    90 minutes

  • Compare vocal efficiency between benign vocal fold lesions and normal voices

    Vocal efficiency is calculated using aerodynamic to acoustic power.

    90 minutes

  • Compare mean airflow rate between benign vocal fold lesions and normal voices

    Mean airflow (I) = Ps / laryngeal resistance (Lr).

    90 minutes

Study Arms (3)

Complete airflow interruption

EXPERIMENTAL
Device: Complete airflow interruption

Incomplete airflow interruption

EXPERIMENTAL
Device: Incomplete airflow interruption

Airflow redirection

EXPERIMENTAL
Device: Airflow redirection

Interventions

Complete airflow interruptionDEVICE

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

Complete airflow interruption
Incomplete airflow interruptionDEVICE

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.

Incomplete airflow interruption
Airflow redirectionDEVICE

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.

Airflow redirection

Eligibility Criteria

Age4 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • Age 4-17
  • Laryngeal pathology
  • No laryngeal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

Study Officials

  • Jack Jiang, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Jiang, MD

CONTACT

608-265-7888jjjiang@wisc.edu

Owen Wischhoff

CONTACT

owischhoff@wisc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

December 22, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 16, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Locations

US(2)