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TY - JOUR

T1 - Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux

T2 - A Double-Blind, Randomized, Sham-Controlled Trial

AU - Schuitenmaker, Jeroen M.

AU - Kuipers, Thijs

AU - Oude Nijhuis, Renske A. B.

AU - Schijven, Marlies P.

AU - Smout, André J. P. M.

AU - Fockens, Paul

AU - Bredenoord, Albert J.

N1 - Funding Information: Jeroen Martin Schuitenmaker, MD (Conceptualization: Equal; Data curation: Equal; Methodology: Equal; Project administration: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Thijs Kuipers, MD (Formal analysis: Equal; Validation: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Renske Oude Nijhuis, MD (Conceptualization: Equal; Data curation: Equal; Project administration: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Marlies P. Schijven, MD PhD (Conceptualization: Supporting; Writing – original draft: Equal; Writing – review & editing: Equal), Andreas J.P.M. Smout, MD PhD (Conceptualization: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Paul Fockens, MD PhD (Conceptualization: Equal; Supervision: Equal; Writing – original draft: Equal; Writing – review & editing: Equal), Albert J. Bredenoord, MD PhD (Conceptualization: Equal; Formal analysis: Equal; Supervision: Equal; Writing – original draft: Equal; Writing – review & editing: Equal) Publisher Copyright: © 2022 The Authors

PY - 2022/12

Y1 - 2022/12

N2 - 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).

AB - 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).

KW - Digital Health

KW - Nocturnal Gastroesophageal Reflux

KW - Sleep

KW - Wearable

UR - http://www.scopus.com/inward/record.url?scp=85134512872&partnerID=8YFLogxK

U2 - 10.1016/j.cgh.2022.02.058

DO - 10.1016/j.cgh.2022.02.058

M3 - Article

C2 - 35301135

VL - 20

SP - 2753-2762.e2

JO - Clinical gastroenterology and hepatology

JF - Clinical gastroenterology and hepatology

SN - 1542-3565

IS - 12

ER -