Hybrid Model of Vocal Inflammation and Tissue Mobilization
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Biomarker levels in laryngeal secretion
研究概览
简要总结
The purpose of this study is to generate a technology that will allow clinicians to prescribe behavioral treatment that should optimize tissue healing for both acute and chronic phonotrauma. In this study, we propose to (1): establish a non-invasive methodology for estimating overall mechanical dose during phonation, and component metrics of phonatory mechanical dose (e.g., distance dose, energy dissipation dose and time dose) from high speed imaging data and aeromechanical modeling, for a range of vocal fold configurations (Experiment 1); (2): identify mathematical relations between treatment dose parameters, inflammatory state of the tissue and time-varying biological consequences in the tissue, up to 2 wk following acute phonotrauma (Experiment 2); (3): develop a hybrid physical-biological model of vocal fold inflammation and treatment to identify treatment modalities that should optimize post-traumatic wound healing at 2 wk, for a range of acute phonotraumatic conditions (Experiment 3-no human subject involved), and (4): provide a preliminary test of the hybrid treatment models' ability to predict idealized treatment outcome in human subjects, and calibrate the model as needed iteratively to achieve a match between predicted and obtained outcomes (Experiment 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy females
- •ages 18-40
- •generally healthy
- •normal hearing bilaterally at 20 dB to 8,000 Hz
- •have ability to produce "resonant voice" during training as determined by the examiner perceptually
- •Tolerate rigid and nasal endoscopy without anesthesia to the larynx nasal patency allowing for the passage of an endoscope unilaterally
排除标准
- •Smoking within the past five yr
- •Failing a hearing screening test
- •Having current chronic voice problems
- •Having current medications that are determined to possibly influence voice
- •Having heightened gag reflex
- •Having known or suspected allergy to anesthetics
- •Pregnancy reported
结局指标
主要结局
Biomarker levels in laryngeal secretion
时间窗: up to 2 months
次要结局
未报告次要终点
研究者
Kittie Verdolini Abbott
Professor
University of Pittsburgh
