NCT06075082

The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastroesophageal Reflux
• Heartburn

Interventions

Type	Name	Description
DEVICE	LEFT smartwatch app	The LEFT smartwatch app is an app on the Apple Watch which measures body sleep position and gently vibrates when the body is in the right lateral decubitus position. In this way, patients with nocturnal gastroesophageal reflux symptoms learn to avoid the right lateral sleep position as they will avoid the annoying vibrations. Measurements while using the smartwatch app will be compared to measurements at baseline.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-07
• Completion: 2024-10-07
• First posted: 2023-10-10
• Last updated: 2025-05-31

Locations

1 site across 1 country: Netherlands