Sleep Position May Reduce Acid Reflux Symptoms at Night
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Number of patients with reduced esophageal acid exposure during sleep [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Number of patients with improved sleep quality [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Number of patients with improved daytime extraesphageal reflux symptoms [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Patients with nocturnal extraesophageal reflux
This is a non-randomized study to evaluate the effectiveness of the MedclineTM Sleep Assist Device on patients who experience nocturnal extraesophageal reflux. All patients will receive the device. Participants will serve as their own controls while undergoing 96-hour pH monitoring. Participants will follow their regular sleep position patterns on Days 1 and 2 of the study and will use the sleep assist device on Days 3 and 4. pH data and patient report of symptoms will be evaluated during the initial 96 hours of the study to capture physiologic results. All participants will use the sleep assist device for the remainder of the study to determine if a reduction in overall reflux symptom index (RSI) is achieved.
Device: MedclineTM Sleep Assist Device
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02320968
|United States, Tennessee|
|Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Michael F Vaezi, MD,PhD||Vanderbilt University|