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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The pillow is designed so that the sleeper can have proper upper-body elevation while sleeping on his or her left side without the need for placing blocks under the head of the bed and bothering anyone else who may be sleeping in the bed. The pillow supports the patient's head, back and body to provide comfort while reducing or relieving acid reflux symptoms during sleep.
Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410
Nashville, Tennessee, United States
Number of patients with reduced esophageal acid exposure during sleep
The patient will use the sleep assist device from days 3 - 30 and will complete various questionnaires at weeks 2 and 4 to determine if night-time reflux symptoms were improved.
Time frame: 30 days
Number of patients with improved sleep quality
The patient will use the sleep assist device from days 3 - 30 and will complete various questionnaires at weeks 2 and 4 to determine if sleep quality and overall quality of life was improved.
Time frame: 30 days
Number of patients with improved daytime extraesphageal reflux symptoms
The patient will use the sleep assist device from days 3 - 30 and will complete various questionnaires at weeks 2 and 4 to determine if sleep quality and overall quality of life was improved.
Time frame: 30 days
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