Aerodynamic Measurements in the Pediatric Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Complete airflow interruption, Incomplete airflow interruption, Airflow redirection.
- Who it may be relevant to
- Registry conditions: Normal Voice. Basic parameters: 4 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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. An adult cohort (ages 18-65) will function as a comparison group for incomplete interruption. 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.
Interventions
- Device Complete airflow interruption
Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve - Device 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. - Device 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 measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 2 centers
- University of Iowa — Iowa City
- University of Wisconsin - Madison — Madison
Identifiers
NCT: NCT06975046 · 2024-1776 · A539770 · SMPH/SURGERY/OTOLARYNGOLOGY · Protocol Version 11/20/2024 · 1R01DC021415