Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux: A Double-Blind, Randomized, Sham-Controlled Trial.

Jeroen M Schuitenmaker, Thijs Kuipers, Renske A B Oude Nijhuis, Marlies P Schijven, André J P M Smout, Paul Fockens, Albert J Bredenoord

Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2022;20(12):2753-2762.e2

PMID: 35301135

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Plain Language Summary

Up to 80% of gastroesophageal reflux disease (GORD) patients experience symptoms during the night, such as heartburn and regurgitation, which can have a profound negative impact on sleep quality and daytime functioning. The aim of this study was to evaluate the effect of sleep positional therapy, using a novel electronic sleep positional therapy wearable device, on sleep position and on nocturnal gastroesophageal reflux symptoms. This study was a single-centre, double-blind, randomised, sham-controlled trial in 100 patients with nocturnal gastroesophageal reflux symptoms. Patients were randomised to one of the two groups (intervention or sham group), and analysed according to the intention-to-treat approach. Results showed that treatment with an electronic sleep positional–wearable device led to an increase in time spent sleeping in the left lateral decubitus position and effectively alleviated nocturnal reflux symptoms compared with sham treatment. Authors conclude that positional therapy can be a valuable addition to other therapeutic strategies in GORD.

Abstract

BACKGROUND & AIMS

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

METHODS

We performed 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 assigned randomly (1:1) to an electronic sleep positional therapy wearable device, programmed to either produce a vibration when in the right lateral position (intervention) or only during the first 20 minutes (sham). The primary outcome was treatment success, defined as a 50% or more reduction in the nocturnal reflux score. Secondary outcomes included change in sleep position and reflux symptoms.

RESULTS

One hundred patients were randomized. In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group (22 of 50) vs 24% in the sham group (12 of 50) (risk difference, 20%; 95% CI, 1.8%-38.2%; P = .03). Treatment led to a significant avoidance of sleeping in the right lateral decubitus position (intervention 2.2% vs sham 23.5%; P = .000) and increased time sleeping in the left lateral decubitus position (intervention 60.9% vs sham 38.5%; P = .000). More reflux-free nights were observed in the intervention group (intervention 9 nights [interquartile range, 6-11 nights] vs sham 6 nights [interquartile range, 3-9 nights]; P = .01).

CONCLUSIONS

Sleep positional therapy using an electronic wearable device promotes sleeping in the left lateral decubitus position and effectively alleviates nocturnal reflux symptoms compared with sham treatment (https://www.trialregister.nl, NL8655).

Address: Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology and Metabolism, University Medical Centers Amsterdam, Amsterdam, The Netherlands. Electronic address: [email protected].; Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology and Metabolism, University Medical Centers Amsterdam, Amsterdam, The Netherlands.; Department of Surgery, Amsterdam Gastroenterology and Metabolism, University Medical Centers Amsterdam, Amsterdam, The Netherlands.

DOI: 10.1016/j.cgh.2022.02.058