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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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 (, NL8655).
Original languageEnglish
Pages (from-to)2753-2762.e2
JournalClinical Gastroenterology and Hepatology
Issue number12
Early online date2022
Publication statusPublished - Dec 2022
Externally publishedYes

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