Normal VoiceNCT06975046
Aerodynamic Measurements in the Pediatric Population
A study testing Complete airflow interruption, Incomplete airflow interruption and Airflow redirection in people with Normal Voice, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Voice
- What is being tested?
- Complete airflow interruption, Incomplete airflow interruption and Airflow redirection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Dec 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 4-65 years
- Normal voice
- No history of voice or other pertinent health disorders
- Age 4-17
- Laryngeal pathology
Who cannot join
- 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
- No laryngeal disorder
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Owen Wischhoff contact
United States2 sites, 2 recruiting
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Matt Hoffman, matthew-r-hoffman@uiowa.edu
Matthew Hoffman, MD
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Jack Jiang, MD, jjjiang@wisc.edu
Jack Jiang, MD
About this study
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.
Read the 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.
- Conditions
- Normal Voice
- Being tested
- Complete airflow interruption, Incomplete airflow interruption, Airflow redirection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete airflow interruptionDevice
Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
Incomplete airflow interruptionDevice
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.
Airflow redirectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Complete airflow interruption | Experimental | Not described Receives: Device: Complete airflow interruption |
| Incomplete airflow interruption | Experimental | Not described Receives: Device: Incomplete airflow interruption |
| Airflow redirection | Experimental | Not described Receives: Device: Airflow redirection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 90 minutes
Compare vocal efficiency between benign vocal fold lesions and normal voices
Vocal efficiency is calculated using aerodynamic to acoustic power.
Measured: 90 minutes
Compare mean airflow rate between benign vocal fold lesions and normal voices
Mean airflow (I) = Ps / laryngeal resistance (Lr).
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start22 Dec 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal VoiceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Jack Jiang, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975046
- Sponsor's protocol ID
- 2024-1776
- Other IDs
- A539770, SMPH/SURGERY/OTOLARYNGOLOGY, Protocol Version 11/20/2024, 1R01DC021415
- Status last verified
- May 2026
- First submitted
- 8 May 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerodynamic Measurements in the Pediatric Population
- ClinicalTrials.gov ID
- NCT06975046
- Acronym / sponsor ID
- 2024-1776
- Conditions
- Normal Voice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- University of Iowa, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Complete airflow interruption | Experimental | Device: Complete airflow interruption |
| Incomplete airflow interruption | Experimental | Device: Incomplete airflow interruption |
| Airflow redirection | Experimental | Device: Airflow redirection |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 4-65 years
- Normal voice
- No history of voice or other pertinent health disorders
- Age 4-17
- Laryngeal pathology
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete airflow interruptionParticipants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve | Device | Complete airflow interruption |
| Incomplete airflow interruptionIncomplete 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 | Incomplete airflow interruption |
| Airflow redirectionParticipant 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. | Device | Airflow redirection |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Owen Wischhoff contact
Jack Jiang, MD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete airflow interruption, Incomplete airflow interruption and Airflow redirection in people with Normal Voice, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jack Jiang, MD (608-265-7888, jjjiang@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare subglottic pressure across different airflow interruption methods (time frame: 60 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.