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Patients with gastroesophageal reflux disease (GERD) who experience nighttime heartburn had symptom alleviation with a wearable electronic sleep positioning device, a Dutch randomized trial found.

In the sham-controlled trial of 100 such patients using the wearable nightly for 2 weeks, 44% of those assigned to the active arm -- where the devices vibrated throughout the night if they rolled onto their right side, a position associated with higher esophageal acid exposure -- had a reduction in GERD symptoms, reported Jeroen Schuitenmaker, MD, of the University Medical Centers Amsterdam, and colleagues.

The reduction was significantly higher compared to those whose sham devices were only set to vibrate during the first 20 minutes (24%; P=0.03).

At 2 weeks, those using the active device had more reflux-free nights (9 vs 6 nights in the sham group; P=0.01), according to the findings in .

"Nocturnal gastroesophageal reflux symptoms, such as heartburn and regurgitation, have a negative impact on sleep quality," Schuitenmaker told 番茄社区app. "Current treatment strategies, including acid suppressive medication, often do not provide sufficient relief."

In the study, patients in the active arm were significantly less likely to end up sleeping in the right lateral decubitus position than those in the sham group (2% vs 24%), and they spent more of their time in the left lateral decubitus position (61% vs 39%), which is associated with less esophageal acid exposure and quicker acid clearance time (P<0.001 for both).

From 2020 to 2021, Schuitenmaker and colleagues randomized 100 patients with nocturnal GERD symptoms to active or sham treatment with the sleep positioning device. All patients were told to sleep on their left side to reduce symptoms. In the intervention arm, the device was programmed to start gently vibrating during the night if the participant turned over to the right lateral position; in the sham group, the device only functioned for the first 20 minutes.

The primary outcome was defined as a 50% or greater reduction in the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire () score.

For inclusion, patients had to have nocturnal heartburn and/or acid reflux symptoms occurring at least three times per week and a total reflux symptom score of ≥8. Those with obstructive sleep apnea and prior gastric/esophageal surgery were excluded, among others.

Because of the pandemic, the double-blinded study was conducted remotely by video, and the devices were sent to participants' homes. The study lasted 5 weeks (2 weeks for baseline measurement, a week for training, and the 2-week study period), and participants were asked to not change their sleep environment or diet. Each participant received a complementary device at study completion.

Average participant age was 52, nearly two-thirds were women, and about half consumed alcohol. About half (47%) were on proton pump inhibitors (PPIs), and 60% were on antacids. One-third only had nighttime symptoms while the remaining had both daytime and nighttime symptoms.

After 2 weeks of treatment, average total N-GSSIQ scores were lower in the active device group (18.8 vs 23.7 in the sham group, P=0.04).

A post-hoc analysis showed that even those on PPIs who did not have a diaphragmatic hernia achieved success with the device.

"Subsequent studies should be performed to see if sleep positional therapy has an effect on esophageal pH parameters or has a role in complicated GERD," said Schuitenmaker. "The results of these studies will follow soon (currently being submitted)."

The authors acknowledged several limitations to the data. Google ad recruitment may have introduced selection bias. No endoscopies or pH monitoring were performed during the study to confirm symptoms, therefore patients without GERD may have been included.

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