A Novel Sleep Positioning Device Reduces Gastroesophageal... : Journal of Clinical Gastroenterology (original) (raw)

ALIMENTARY TRACT: Original Articles

A Randomized Controlled Trial

Person, Erik MD*; Rife, Christopher MD†; Freeman, Janice RN†; Clark, Aaron‡; Castell, Donald O. MD†

*University of Maryland Gastroenterology, Baltimore, MD

†Medical University of South Carolina Gastroenterology, Charleston, SC

‡Amenity Health Inc., San Diego, CA

No authors received any financial compensation for conduction of the study or preparation of the manuscript. Study was funded by a grant to the institution from Amenity Health Inc.

This abstract was presented as an oral presentation in San Diego at the ACG National Conference in October, 2013 and Erik Person, MD (first author) was awarded an ACG/AstraZeneca Fellow Award for his work.

Conflict of interest: Amenity Health, Inc. (maker of Medcline sleep positioning device) paid for the entire study in full. In addition, they were involved in the editing process of the manuscript. All parts of the study were sent to their office for free viewing and opinions. A.C. is an employee of Amenity Health, Inc. and assisted in setting up and interpreting the position monitor data. The remaining authors declare that they have nothing to disclose.

Reprints: Erik B. Person, MD, University of Maryland Medical Center, 3621 Roland Ave. Apt B, Baltimore, MD 21211 (e-mail: [email protected]).

Received February 16, 2015

Accepted April 27, 2015

Abstract

Goal:

We hypothesized that sleeping left-side down with the head/torso elevated reduces recumbent gastroesophageal reflux (GER).

Background:

Previous studies show that sleeping with head of bed elevated or on wedge reduces GER and lying left-side down reduces GER versus right-side down and supine. No prior studies have evaluated the potential compounding effects of lying in an inclined position combined with lateral positioning on GER.

Study:

We evaluated a sleep-positioning device (SPD) consisting of an inclined base and body pillow that maintains lateral position while elevating the head/torso. This was a single institution, randomized controlled trial involving 20 healthy volunteers receiving 4 six-hour impedance-pH tests. After placement of reflux probe, subjects returned home, ate standardized meal, and lay down in randomly assigned positions: SPD right-side down (SPD-R), SPD left-side down (SPD-L), standard wedge any position (W), or flat any position (F). A wireless accelerometer documented position during each study. Number of reflux episodes (RE) and esophageal acid exposure (EAE) were calculated over 6 hours.

Results:

Significantly less EAE occurred during sleeping SPD-L versus sleeping W, SPD-R, and F. The most EAE occurred during sleeping SPD-R despite use of the positioning device. RE were significantly less SPD-L than SPD-R. Patients sleeping SPD-L and SPD-R spent the majority of first 2 hours and greater than half of 6 hours in assigned position. Patients sleeping W and F averaged more time supine than right or left.

Conclusions:

The sleep positioning device maintains recumbent position effectively. Lying left-side down, it reduces recumbent esophageal acid exposure.