Esophagus to Small Intestine
Clin Gastroenterol Hepatol. 2022;20(12):2753–62.e2
Sleep positional therapy for nocturnal gastroesophageal reflux: A double-blind, randomized, sham-controlled trial
Background and 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: The authors 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: 100 patients were randomized. In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group (22/50) versus 24% in the sham group (12/50) (risk difference, 20%; 95% confidence interval [CI]: 1.8–38.2%; p = 0.03). Treatment led to a significant avoidance of sleeping in the right lateral decubitus position (intervention 2.2% vs. sham 23.5%; p = 0.000) and increased time sleeping in the left lateral decubitus position (intervention 60.9% vs. sham 38.5%; p = 0.000). More reflux-free nights were observed in the intervention group (intervention 9 [interquartile range {IQR}, 6–11] nights vs. sham 6 [IQR, 3–9] nights; p = 0.01).
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.