Complete airflow interruption
DeviceParticipants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
Recruiting
NCT Number: NCT06975046
Aerodynamic Measurements in the Pediatric Population
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
4 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Iowa, Iowa City, Iowa, United States
Loading trial locations.
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Incomplete airflow interruption
DeviceIncomplete 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.
Airflow redirection
DeviceParticipant 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 outcomes
-
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.
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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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Wisconsin, Madison
Other
Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- University of Iowa
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- May 16, 2025
- Registry last updated
- May 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.