Positional Therapy Alleviates Nocturnal Gastroesophageal Reflux

Up to 80% of patients with gastroesophageal reflux disease (GERD) experience symptoms at night, such as heartburn and regurgitation, which can have a profound negative impact on sleep quality and daytime functioning.

Lifestyle measures, such as raising the head of the bed and prolonging the time between dinner and bedtime, often do not provide enough relief. The use of proton pump inhibitors (PPIs) is very effective for daytime symptoms, but has limited effectiveness for nocturnal reflux symptoms. Other solutions are therefore of great interest.

Patients often report having more reflux symptoms when sleeping in the right lateral decubitus position. In fact, experimental studies have suggested that the right lateral decubitus position is associated with a longer exposure time to esophageal acid and slower esophageal acid clearance compared to the left lateral decubitus position.

One mechanism proposed to explain this is that in the right lateral decubitus position, the stomach is positioned above the esophagus, resulting in more reflux. Therefore, interventions aimed at promoting the left lateral decubitus sleep position (and avoiding the right lateral decubitus position) could alleviate nocturnal reflux symptoms.

Anti-reflux pillows, which attempt to maintain the left lateral recumbent position at night, have been found to result in less acid exposure in the reclined position and fewer self-reported nocturnal reflux symptoms.

However, these pillows do not allow for spontaneous body movements and can therefore be uncomfortable. Electronic sleep position trainers, worn directly on the body, may provide a therapeutic alternative to these pillows. The effectiveness of electronic sleep position training devices has already been tested in patients with sleep apnea and excessive snoring.

Patients with apnea can be trained through vibration to roll from their back to the left or right side. By adapting the vibration/position threshold of such a device, we assumed that it would be possible to train patients suffering from nocturnal reflux symptoms to sleep on their left side, thereby reducing their complaints.

Therefore, the aim of this study was to evaluate the effect of positional sleep therapy, using a novel portable electronic positional sleep therapy device, on sleeping position and nocturnal gastroesophageal reflux symptoms.

Background and objectives

Experimental studies have suggested that sleeping position plays a role in the occurrence of nocturnal gastroesophageal reflux, with the left lateral recumbent position being the most favorable. The aim of this study was to evaluate the effect of a novel wearable electronic sleep positional therapy device on sleep position and nocturnal reflux symptoms.

Methods

We conducted a double-blind, randomized, sham-controlled trial in patients with nocturnal symptoms of gastroesophageal reflux. Patients were advised to sleep in the left lateral decubitus position and were randomly assigned (1:1) to a wearable electronic positional sleep therapy device, programmed to produce a vibration when in the right lateral position (intervention). or only during the first 20 days. minutes (false).

The primary outcome was treatment success, defined as a 50% or greater reduction in nocturnal reflux score. Secondary outcomes included changes in sleeping position and reflux symptoms.

Portable positional sleep therapy device. The device is placed on the middle of the breastbone with an adhesive label and is activated by pressing the button on the device when lying down. The device records a subject’s sleeping position at 30-second intervals. Created with BioRender

Results

One hundred patients were randomized. In the intention-to-treat analysis, the treatment success rate was 44% in the intervention group (22 of 50) versus 24% in the sham group (12 of 50) (risk difference, 20%). ; 95% CI, 1.8%–38.2%; p = 0.03).

Treatment led to significant avoidance of sleeping in the right lateral decubitus position (intervention 2.2% vs. sham 23.5%; P = 0.000) and increased sleep time in the left lateral decubitus position (intervention 60.9% vs. sham 38.5%; P = 0.00). 000).

More reflux-free nights were observed in the intervention group (9 intervention nights [interquartile range, 6 to 11 nights] versus 6 sham nights [interquartile range, 3 to 9 nights]; P = 0.01).

Conclusions

In patients with nocturnal gastroesophageal reflux symptoms, treatment with a portable electronic positional sleeping device promotes left lateral decubitus sleep and effectively relieves symptoms. These results indicate that positional therapy may be a valuable addition to the therapeutic arsenal in GERD.

Discussion

Nocturnal reflux symptoms can negatively impact sleep quality and are associated with more severe phenotypes of reflux disease, such as erosive reflux esophagitis, Barrett’s esophagus, and esophageal cancer.

PPIs are very effective for treating daytime GERD, but less effective for nocturnal symptoms due to nocturnal acid breakthrough and persistent weak acid reflux.

In this double-blind, randomized, sham-controlled trial of 100 patients with nocturnal symptoms of gastroesophageal reflux, we evaluated the effect of positional therapy, using a novel portable electronic positional sleep therapy device, on sleeping position and symptoms of nocturnal gastroesophageal reflux. Our results show that treatment with this device increased left lateral decubitus sleep time and effectively relieved nocturnal reflux symptoms compared with sham treatment.

(https://www.trialregister.nl, NL8655).