Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
365 participants
INTERVENTIONAL
2025-12-31
2030-12-31
Brief Summary
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* 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
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Complete airflow interruption
Complete airflow interruption
Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
Incomplete airflow interruption
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.
Airflow redirection
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.
Interventions
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Complete airflow interruption
Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Normal voice
* No history of voice or other pertinent health disorders
* Age 4-17
* Laryngeal pathology
Exclusion Criteria
* 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
4 Years
17 Years
ALL
Yes
Sponsors
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University of Iowa
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Jack Jiang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Iowa
Iowa City, Iowa, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Matt Hoffman
Role: primary
Jack Jiang, MD
Role: primary
Other Identifiers
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A539770
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY/OTOLARYNGOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 11/20/2024
Identifier Type: OTHER
Identifier Source: secondary_id
2024-1776
Identifier Type: -
Identifier Source: org_study_id