Aerodynamic Measurements in the Pediatric Population

University of Wisconsin (UW)

Status: Enrolling

Conditions: Normal Voice

Treatments: Device: Incomplete airflow interruption; Device: Airflow redirection; Device: Complete airflow interruption

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06975046

2024-1776

A539770 (Other Identifier)

SMPH/SURGERY/OTOLARYNGOLOGY (Other Identifier)

1R01DC021415 (U.S. NIH Grant/Contract)

Protocol Version 11/20/2024 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 365 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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365 participants in 3 patient groups

Complete airflow interruption

Experimental group

Treatment:

Device: Complete airflow interruption

Incomplete airflow interruption

Experimental group

Treatment:

Device: Incomplete airflow interruption

Airflow redirection

Experimental group

Treatment:

Device: Airflow redirection