An interventional study of Complete airflow interruption and Incomplete airflow interruption in Normal Voice, sponsored by University of Wisconsin, Madison. Recruiting at 2 sites in United States. Open to participants aged 4 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Other
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:
Participants will complete one 60 minute session involving one of three types of aerodynamic interruption.
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.
University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Healthy Control:
Exclusion Criteria - Healthy Control:
Inclusion Criteria - Abnormal Voice:
Exclusion Criteria - Abnormal Voice:
Device: Complete airflow interruption
Device: Incomplete airflow interruption
Device: Airflow redirection
Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
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.
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.
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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 90 minutes
Compare vocal efficiency between benign vocal fold lesions and normal voices
Vocal efficiency is calculated using aerodynamic to acoustic power.
Time frame: 90 minutes
Compare mean airflow rate between benign vocal fold lesions and normal voices
Mean airflow (I) = Ps / laryngeal resistance (Lr).
Time frame: 90 minutes
Plan to share: Yes
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University of Wisconsin, Madison