Aerodynamic Measurements in the Pediatric Population
Purpose
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.
Condition
- Normal Voice
Eligibility
- Eligible Ages
- Between 4 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Complete airflow interruption |
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|
|
Experimental Incomplete airflow interruption |
|
|
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Experimental Airflow redirection |
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Recruiting Locations
More Details
- NCT ID
- NCT06975046
- Status
- Recruiting
- Sponsor
- University of Wisconsin, Madison
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.