Aerodynamic Measurements in the Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 365
- 试验地点
- 2
- 主要终点
- Compare subglottic pressure across different airflow interruption methods
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Control:
- •Age 4-65 years
- •Normal voice
- •No history of voice or other pertinent health disorders
排除标准
- •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:
- •Laryngeal pathology
- •Exclusion Criteria - Abnormal Voice:
- •No laryngeal disorder
研究组 & 干预措施
Complete airflow interruption
干预措施: Complete airflow interruption (Device)
Incomplete airflow interruption
干预措施: Incomplete airflow interruption (Device)
Airflow redirection
干预措施: Airflow redirection (Device)
结局指标
主要结局
Compare subglottic pressure across different airflow interruption methods
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 90 minutes
Vocal efficiency is calculated using aerodynamic to acoustic power.
Compare mean airflow rate between benign vocal fold lesions and normal voices
时间窗: 90 minutes
Mean airflow (I) = Ps / laryngeal resistance (Lr).
次要结局
未报告次要终点