Sleep Position May Reduce Acid Reflux Symptoms at Night

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.

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