Clinical trial NCT02320968: Sleep Position May Reduce Acid Reflux Symptoms at Night
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Extra-esophageal Reflux
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Amenity Health, Inc.
First posted: 2014-12-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients with reduced esophageal acid exposure during sleep
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients with improved sleep quality
timeFrame: 30 days
measure: Number of patients with improved daytime extraesphageal reflux symptoms
timeFrame: 30 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Michael F Vaezi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: