The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ)
研究概览
简要总结
The main objectives of the study are (1) to investigate if sleep positional therapy, using the LEFT smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with gastroesophageal reflux disease symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.
详细描述
Gastroesophageal reflux disease (GERD) is one of the most common gastro-intestinal disorders and approximately 50-80% of the GERD patients experience nocturnal gastroesophageal reflux symptoms. Symptoms at night have a negative impact on sleep quality, daytime functioning and quality of life. When sleeping in left lateral decubitus position, the stomach is positioned below the esophagus, resulting in less reflux compared to sleeping in right lateral decubitus position. Sleep positional therapy, using an electronic wearable device which gently vibrates in an annoying way when turning in the sleep to the disadvantageous right lateral decubitus position, stimulates subjects to avoid sleeping in the right lateral decubitus position and effectively alleviates nocturnal gastroesophageal reflux symptoms. This prospective single center interventional pilot study will aim to (1) investigate if sleep positional therapy, using the LEFT smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with GERD symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Both male and female patients will be included.
- •Age 18 years or older.
- •Symptoms of heartburn and/or acid regurgitation during at least three nights a week.
- •A total reflux symptom score ≥8 (measured through the GERDQ questionnaire score).
- •Able to wear the Apple Watch on the left wrist.
排除标准
- •Complete PPIs non-responders.
- •Nightshift workers
- •Surgery of the esophagus or stomach.
- •Regular use of sleep medication (benzodiazepines) or medication which affect gastrointestinal motility (e.g. prokinetics or opioids) that cannot be stopped during the duration of the trial.
- •Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
- •Patients with obstructive sleep apnea or esophageal motility disorders.
- •Pregnant or lactating women.
结局指标
主要结局
Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ)
时间窗: 2 weeks
The primary efficacy measure is relative change in total nocturnal gastroesophageal reflux symptoms measured by the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ). The N-GSSIQ is a 20-item questionnaire measuring the severity, morning impact and concern about nocturnal gastro-esophageal reflux disease. The N-GSSIQ is a validated questionnaire to assess nocturnal GERD symptom severity over the past 2 weeks. The N-GSSIQ is comprised of three subscales: Nocturnal Gastroesophageal Reflux Disease Symptom Severity (13 questions, score range 0-65), Morning Impact of Nocturnal Gastroesophageal Reflux Disease (2 questions, score range 0-10), and Concern about Nocturnal Gastroesophageal Reflux Disease (5 questions, score range 0-20). Total score ranging from 0 to 95. A higher score indicates more severe symptoms.
次要结局
- Treatment success(2 weeks)
- Change in total Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score.(2 weeks)
- Sleep position(2 weeks)
- Number of nocturnal reflux free nights(2 weeks)
- Reflux disease questionnaire (RDQ)(2 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(2 weeks)
- Functional Outcomes of Sleep Questionnaire (FOSQ)(2 weeks)
研究者
Prof.dr. A.J. (Arjan) Bredenoord
Prof. dr. A.J. Bredenoord
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)