Voice Quality Analysis of Patients With Laryngotracheal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Voice Quality in patients with idiopathic subglottic stenosis
研究概览
简要总结
The investigators previously demonstrated that voice changes are common in patients with Laryngotracheal Stenosis (LTS), and patients typically report an improvement in voice outcomes following endoscopic dilation. Recently, NIH based programs such as a Bridge to Artificial Intelligence (Bridge2AI) have highlighted the use of artificial intelligence to identify acoustic biomarkers of disease. Therefore, the investigators hypothesize that progression of LTS scar can be quantified using acoustic measurements and machine learning. The goal of this clinical trial is to remotely monitor patient voice quality in an effort to determine if regularly performed voice recordings can be used as a diagnostic tool in order to predict the need for dilation procedures. The investigators feel that successful use of remote voice recording technology with algorithmic analysis will improve patient quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of laryngotracheal stenosis
- •Patient age 18 - 80 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- •The patient must be able to comprehend and have signed the informed consent.
- •The patient must have documentation of their date of laryngotracheal stenosis diagnosis and prior medical/surgical history.
排除标准
- •Inability to use the app associated with the study.
- •Comorbid laryngeal or glottic disease
- •Concurrent neurological disease which may impact voice use (such as tremor, parkinsonism, laryngeal dystonia)
结局指标
主要结局
Voice Quality in patients with idiopathic subglottic stenosis
时间窗: Baseline, 14 days, monthly for 2 years
To remotely assess voice quality of patients with idiopathic subglottic stenosis with VoiceLab automated voice analysis software both before and at regular intervals following dilation procedures
次要结局
- Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score(Baseline, 14 days, monthly for 2 years)
- Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score(Baseline, 14 days, monthly for 2 years)
- Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis(Baseline, 14 days, monthly for 2 years)
- Change in Clinical COPD Questionnaire Quality of Life Score(Baseline, 14 days, monthly for 2 years)
- Change in lumen surface area(2 years or when surgical intervention is required if before 2 years)