Sleep Position Reduces Acid Reflux and Decreases Extraesophageal Reflux Symptoms: A Non-randomized Prospective Study of the Amenity Health MedclineTM Sleep Assist Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of patients with reduced esophageal acid exposure during sleep
研究概览
简要总结
This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.
详细描述
The MedcineTM Sleep Assist Device was recently developed by Amenity Health, Inc and is designed to elevate the head and torso and maintain a patient in the left-lateral position in order to decrease night-time/nocturnal acid reflux. The MedcineTM Sleep Assist Device is composed of a 9-inch incline base and a wrap-around body pillow. Traditionally wedge pillows have been recommended for patients with acid reflux. The addition of the body pillow helps to maintain the patient in the left-lateral position (LLP) during sleep, which has been shown to reduce night-time reflux compared to wedge alone, right lateral position and/or sleeping flat.
In healthy controls, sleeping in the left-lateral position with this device system significantly decreased esophageal acid exposure and overall episodes of acid reflux. To date, there has been no study in patients with extra-esophageal reflux (EER) and nocturnal heartburn.
Primary Objectives The primary objective of the this study is to evaluate the effect of a reflux pillow on esophageal acid exposure in patients complaining of nocturnal EER.
Secondary Objectives To evaluate the effect of the reflux pillow on nocturnal EER symptoms, sleep quality, daytime EER symptoms, and overall quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between the ages of 18 and 65;
- •Between 5'4" and 6'2"
- •Body Mass Index<32
- •Willing and able to provide written informed consent;
- •Understands the clinical study requirements and is able to comply with the follow-up schedule set forth in the protocol;
- •Clinically diagnosed with gastroesophageal reflux disease with extra-esophageal symptoms (i.e. chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing);
- •Presents with Reflux Symptom Index (RSI) > 13;
- •Undergoing Esophagogastroduodenoscopy (EGD) as part of routine care;
- •Undergoing 96-hour pH monitoring via BRAVO capsule as part of routine care.
排除标准
- •Currently being treated with another investigational medical device and/or drug;
- •Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP);
- •Female patients who are of child-bearing potential and not using an acceptable method of birth control, or is pregnant or breast-feeding;
- •Suspected esophageal cancer;
- •Confirmed nasopharyngeal cancer;
- •Previously undergone Nissen Fundoplication;
- •Hiatal hernia > 4 cm
结局指标
主要结局
Number of patients with reduced esophageal acid exposure during sleep
时间窗: 30 days
The patient will use the sleep assist device from days 3 - 30 and will complete various questionnaires at weeks 2 and 4 to determine if night-time reflux symptoms were improved.
次要结局
- Number of patients with improved sleep quality(30 days)
- Number of patients with improved daytime extraesphageal reflux symptoms(30 days)
研究者
Michael Vaezi
Principal Investigator
Vanderbilt University Medical Center