Clinical trial NCT06975046: Aerodynamic Measurements in the Pediatric Population
Official title: Aerodynamic Measurements in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Normal Voice
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2025-05-16
Enrollment: 365
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to create a vocal health database of people aged 4-17 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. 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

Eligibility criteria: Inclusion Criteria - Healthy Control:

* Age 4-17 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

Primary outcomes:
measure: Compare subglottic pressure across different airflow interruption methods
timeFrame: 60 minutes
measure: Compare phonation threshold pressure (PTP) across airflow interruption methods
timeFrame: 60 minutes
measure: Compare laryngeal resistance across airflow interruption methods
timeFrame: 90 minutes
measure: Compare subglottic pressure between benign vocal fold lesions and normal voices
timeFrame: 90 minutes
measure: Compare PTP between benign vocal fold lesions and normal voices
timeFrame: 90 minutes
measure: Compare laryngeal resistance between benign vocal fold lesions and normal voices
timeFrame: 90 minutes
measure: Compare vocal efficiency between benign vocal fold lesions and normal voices
timeFrame: 90 minutes
measure: Compare mean airflow rate between benign vocal fold lesions and normal voices
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jack Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: