Gastroesophageal reflux disease heartburn
Conditions
Interventions
The SNOOOR device is worn on the upper chest and is designed to measure sleep
position and stimulate to avoid the supine sleeping position in subjects with
positional snoring. It is normally program
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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 disorder. • Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in total nocturnal gastroesophageal reflux symptoms measured by N-GSSIQ. | — |
Secondary
| Measure | Time frame |
|---|---|
| • % responders as treatment success, defined as subjects with a minimal 50% reduction in nocturnal gastroesophageal reflux symptoms measured by N-GSSIQ • Change in total N-GSSIQ. • Change in sleep position (supine, prone or left or right lateral decubitus). • Change in nocturnal reflux free nights measured by daily symptom diary. • Change in reflux symptoms measured by RDQ • Change in sleep quality and effect on daily (working) life measured by PSQI and FOSQ-10. | — |
Countries
Netherlands
Outcome results
None listed