跳至主要内容
临床试验/NCT01197339
NCT01197339已完成1 期

Hybrid Model of Vocal Inflammation and Tissue Mobilization

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kittie Verdolini Abbott

Professor

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验