NCT06975046 · University of Wisconsin, Madison
Aerodynamic Measurements in the Pediatric Population
What this study is about
The goal of this clinical trial is to create a vocal health database of people aged 4-65 with no diagnosed voice pathology.
View original scientific description
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.
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
Subglottic pressure is measured in kPa of leakage of air between the vocal folds and the resistance to that flow during speech
Compare phonation threshold pressure (PTP) across airflow interruption methods
Time frame: 60 minutes
PTP is is calculated by subtracting the intraoral pressure at phonation cessation from the subglottal pressure (Ps).
Compare laryngeal resistance across airflow interruption methods
Time frame: 90 minutes
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.
Compare subglottic pressure between benign vocal fold lesions and normal voices
Time frame: 90 minutes
Subglottic pressure is measured in kPa of leakage of air between the vocal folds and the resistance to that flow during speech
Compare PTP between benign vocal fold lesions and normal voices
Time frame: 90 minutes
PTP is is calculated by subtracting the intraoral pressure at phonation cessation from the subglottal pressure (Ps).
Compare laryngeal resistance between benign vocal fold lesions and normal voices
Time frame: 90 minutes
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.
Compare vocal efficiency between benign vocal fold lesions and normal voices
Time frame: 90 minutes
Vocal efficiency is calculated using aerodynamic to acoustic power.
Compare mean airflow rate between benign vocal fold lesions and normal voices
Time frame: 90 minutes
Mean airflow (I) = Ps / laryngeal resistance (Lr).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Laryngeal pathology Exclusion Criteria - Abnormal Voice:
- No laryngeal disorder
Where
- Iowa City, Iowa
- Madison, Wisconsin
Collaborators
University of Iowa, National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations