Sleep Position May Reduce Acid Reflux Symptoms at Night

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02320968
• Other study ID #: 141619
• Status: Terminated
• Phase: N/A
• First received: December 11, 2014
• Last updated: April 27, 2017
• Start date: December 2014
• Est. completion date: March 1, 2017

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female patients between the ages of 18 and 65;

• Between 5'4" and 6'2"

• Body Mass Index<32

• Willing and able to provide written informed consent;

• Understands the clinical study requirements and is able to comply with the follow-up schedule set forth in the protocol;

• Clinically diagnosed with gastroesophageal reflux disease with extra-esophageal symptoms (i.e. chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing);

• Presents with Reflux Symptom Index (RSI) > 13;

• Undergoing Esophagogastroduodenoscopy (EGD) as part of routine care;

• Undergoing 96-hour pH monitoring via BRAVO capsule as part of routine care.

Exclusion Criteria:

• Currently being treated with another investigational medical device and/or drug;

• Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP);

• Female patients who are of child-bearing potential and not using an acceptable method of birth control, or is pregnant or breast-feeding;

• Suspected esophageal cancer;

• Confirmed nasopharyngeal cancer;

• Previously undergone Nissen Fundoplication;

• Hiatal hernia > 4 cm

Related Conditions & MeSH terms

• Extra-esophageal Reflux
• Gastroesophageal Reflux

Intervention

Other:
• MedclineTM Sleep Assist Pillow
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Amenity Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	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.	30 days
Secondary	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.	30 days