Sleep Position May Reduce Acid Reflux Symptoms at Night

Stopped early · Not applicable

Conditions studied: Extra-esophageal Reflux

In brief

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

Key facts

Study ID: NCT02320968
Run by: Vanderbilt University Medical Center
People needed: 10
Starts: 2014-12-01
Expected to finish: 2017-03-01
Last updated by the study team: 2017-05-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410 — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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