Using a smartwatch app to help reduce nighttime acid reflux symptoms
The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
This study is testing a smartwatch app that helps people with GERD reduce nighttime acid reflux by gently reminding them to sleep in a better position.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT06075082 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the LEFT smartwatch app in reducing nocturnal gastroesophageal reflux symptoms in patients suffering from gastroesophageal reflux disease (GERD). The app employs sleep positional therapy by gently vibrating to encourage users to avoid sleeping in the right lateral position, which is associated with increased reflux. The study aims to assess whether this intervention can improve sleep quality and overall quality of life for affected individuals. It is a prospective, single-center, interventional pilot study focused on patients experiencing frequent nighttime reflux symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who experience heartburn or acid regurgitation at least three nights a week.
Not a fit: Patients who are complete non-responders to proton pump inhibitors or have severe concomitant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate nighttime gastroesophageal reflux symptoms, improving patients' sleep quality and daily functioning.
How similar studies have performed: While the specific use of a smartwatch app for this purpose is novel, sleep positional therapy has shown promise in other studies for managing gastroesophageal reflux symptoms.
Eligibility criteria
Show full inclusion / exclusion 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: * 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.
Where this trial is running
Amsterdam, Noord-Holland
- Amsterdam UMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Elise M Wessels, dr.
- Email: e.wessels@amsterdamumc.nl
- Phone: +31205667805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.