Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
研究概览
简要总结
This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.
详细描述
Reflux associated laryngeal symptoms, coined "laryngopharyngeal reflux", occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-89 years male and female,
- •>8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness,
- •naïve to PPI or able to stop for 8 weeks
排除标准
- •Laryngeal mass lesion on laryngoscopy;
- •Pregnant;
- •Unable to consent in English;
- •Imprisoned;
- •PPI intolerance;
- •Contraindication to UESAD use per manufacturer guidelines which include:
- •Patients with implants or implant parts that reside in the area where UESAD is applied.
- •Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
- •Patients diagnosed with glaucoma.
- •Patients who had a malignancy of the neck, including neck surgery.
- •Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
- •Patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome).
- •Patients who use nocturnal NIV machines such as CPAP or BiPAP.
结局指标
主要结局
Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
时间窗: Week 4
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
次要结局
未报告次要终点
研究者
Rena Yadlapati
Principal Investigator
University of California, San Diego