Extra-esophageal Reflux Clinical Trial
Official title:
Sleep Position Reduces Acid Reflux and Decreases Extraesophageal Reflux Symptoms: A Non-randomized Prospective Study of the Amenity Health MedclineTM Sleep Assist Device
This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.
The MedcineTM Sleep Assist Device was recently developed by Amenity Health, Inc and is
designed to elevate the head and torso and maintain a patient in the left-lateral position
in order to decrease night-time/nocturnal acid reflux. The MedcineTM Sleep Assist Device is
composed of a 9-inch incline base and a wrap-around body pillow. Traditionally wedge pillows
have been recommended for patients with acid reflux. The addition of the body pillow helps
to maintain the patient in the left-lateral position (LLP) during sleep, which has been
shown to reduce night-time reflux compared to wedge alone, right lateral position and/or
sleeping flat.
In healthy controls, sleeping in the left-lateral position with this device system
significantly decreased esophageal acid exposure and overall episodes of acid reflux. To
date, there has been no study in patients with extra-esophageal reflux (EER) and nocturnal
heartburn.
Primary Objectives The primary objective of the this study is to evaluate the effect of a
reflux pillow on esophageal acid exposure in patients complaining of nocturnal EER.
Secondary Objectives To evaluate the effect of the reflux pillow on nocturnal EER symptoms,
sleep quality, daytime EER symptoms, and overall quality of life.
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