Sleep Position May Reduce Acid Reflux Symptoms at Night

NCT ID: NCT02320968

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-03-01

Brief Summary

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

Detailed 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.

Conditions

Extra-esophageal Reflux

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MedclineTM Sleep Assist Pillow

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amenity Health, Inc.

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Vaezi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael F Vaezi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

141619

Identifier Type: -

Identifier Source: org_study_id