跳至主要内容
临床试验/NCT04500288
NCT04500288进行中(未招募)不适用

The Effect of Positional Therapy on Symptoms of Gastroesophageal Reflux Disease: A Prospective Pilot Study

MetroHealth Medical Center2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
15
试验地点
2
主要终点
The primary outcome of the study is to determine if positional therapy, using the LEFT device, is effective in improving nighttime GERD-related symptoms as measured by GERD symptoms checklist (questionnaire, involves no specific units of measure).

研究概览

简要总结

Gastroesophageal reflux disease related symptoms are reported by 10-20% of the adult population and of those 50-75% report symptoms during sleep time. The prevalence of nocturnal GERD (nGERD) is estimated to be about 25% in general population. nGERD causes sleep fragmentation, difficulty falling asleep, daytime sleepiness, reduced work productivity and decreased quality of life. Additionally, nighttime gastroesophageal reflux has been associated with increased risk of GERD-related complications such as severe erosive esophagitis, peptic stricture, esophageal ulcer, Barrett's esophagus, and esophageal adenocarcinoma. Furthermore, nocturnal gastroesophageal reflux has been noted to be associated with atypical and extra-esophageal manifestations as well as sleep disturbances. Overall, patients with nocturnal gastroesophageal reflux are more likely to develop a more severe form of GERD. The mainstay of treatment of nighttime gastroesophageal reflux is a proton pump inhibitor (PPI). However, nighttime heartburn is the most common breakthrough symptom in patients with GERD, who failed PPI treatment. Other important therapies for nighttime GERD include, lifestyle modifications, such as elevating the head of the bed, avoiding eating at least three hours before bedtime, maintaining appropriate sleep hygiene and avoiding the right decubitus position. Elevating the upper torso by raising the head of the bed and avoiding the right-lateral decubitus position have been shown to improve nocturnal symptoms. Several studies have shown that sleeping in the left decubitus position decrease esophageal acid exposure by reducing 13-76% of the reflux episodes. Studies have shown that the right decubitus position increases the rate of transient lower esophageal sphincter relaxations (TLESRs) accompanied by acid reflux, as compared with the left recumbent position. Moreover, maintaining the left lateral recumbent position, reduced by 87% esophageal acid exposure and nocturnal symptoms.

LEFT is a novel electronic wearable device that was developed as a sleep position therapy for patients who suffer from nighttime gastroesophageal reflux symptoms. It is simple, noninvasive and low-cost technology which has been developed by Side Sleep Technologies B.V. Singel, Amesterdam, The Netherland.

This technology is designed to train patients to sleep on their left side by a gentle vibration signal once it detects that they are sleeping on their back or right side. Thus, this technique may reduce gastroesophageal reflux and thus provides relief of heartburn and regurgitation during sleep time. The purpose of this study is to determine the usefulness of positional therapy, using the LEFT device, as a nonmedical tool to control GERD-related nocturnal symptoms.

详细描述

Study Aims

  1. The primary outcome of the study is to determine if positional therapy, using the LEFT device, is effective in improving nighttime GERD-related symptoms.
  2. The secondary outcome of the study is to determine if positional therapy improves quality of sleep and health-related quality of life.

Methods:

Study Design This is a prospective, pilot study, that will be conducted at the Esophageal and Swallowing Center outpatient clinic at MetroHealth Medical Center. A total of 15 patients will be assessed for eligibility for the study. GERD patients will be recruited from the Esophageal and Swallowing Center outpatient clinic. Subjects with nighttime, GERD-related symptoms, at least three times a week will be recruited into the study. Nighttime symptoms are defined in this study as symptoms that awaken patients from sleep during the night. Subjects that meet inclusion and exclusion criteria will complete baseline pre-treatment validated questionnaires including, the Demographics Questionnaire, SF-36, GERD symptoms checklist, Berlin Questionnaire, Epworth Sleepiness Scale and Sleep quality questionnaire. Subsequently, patients will be trained on how to use the LEFT device. Prior to initiation of the study, the patients will undergo baseline symptoms assessment using the 7-day symptom record diary. Thereafter, patients will undergo positional therapy using the LEFT device for a period of one month. During the last week of the month, patients will undergo again the 7-day symptom record diary. On the last day of the month, patients will be asked to complete the following questionnaires, GERD symptoms checklist, Sleep quality questionnaire, and SF-36. The device well be returned together with the questionnaires by the patient.

Study population The study population will include patients with nocturnal GERD symptoms as previously defined, from our Esophageal and Swallowing Center outpatient clinic of MetroHealth Medical Center, main campus. Patients with at least three days of nighttime symptoms will be included in the study. Patients will be identified by clinical staff including attending physicians, GI fellows and Internal Medicine residents.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over the age of 18 who have proven GERD (with nighttime heartburn at least 3 days a week).
  • Agree to undergo sleep positioning therapy.
  • Able to read, understand, and complete study questionnaires.
  • Have mobile phones with an operating system (Android or iOS) that supports the LEFT device.

排除标准

  • Patients who are under the age of 18.

结局指标

主要结局

The primary outcome of the study is to determine if positional therapy, using the LEFT device, is effective in improving nighttime GERD-related symptoms as measured by GERD symptoms checklist (questionnaire, involves no specific units of measure).

时间窗: 1 month

Patients will undergo positional therapy using the LEFT device for a period of one month

次要结局

  • The secondary outcome of the study is to determine if positional therapy improves quality of sleep and health-related quality of life as measured by Epworth Sleepiness, Scale and Sleep quality, SF-36 and Berlin questionnaires. No units of measure.(1 month)

研究者

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

RONNIE FASS

Ronnie Fass, MD, FACG, Director, Division of Gastroenterology and Hepatology, Head, Esophageal and Swallowing Center

MetroHealth Medical Center

研究点 (2)

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