Pillow System Significantly Improves Nocturnal GERD Symptoms

Study shows device could replace traditional therapies

Although researchers have known for 25 years that sleeping at an incline decreases reflux, a recent Cleveland Clinic study found that a sleep positioning device, the Medcline™ sleep system, significantly decreases nocturnal gastroesophageal reflux disease (GERD).

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Cleveland Clinic’s Scott Gabbard, MD, of the Digestive Disease Institute, tested the use of the sleep positioning device using a two-component incline base with a wrap-around body pillow shaped like a candy cane in patients with nocturnal GERD and on proton pump inhibitors. A previous study revealed the sleep positioning device decreased nocturnal acid reflux in healthy volunteers.

“The whole point of the study was to see if it improves symptoms for which the pillow was developed,” Dr. Gabbard says, indicating Cleveland Clinic is the only institution studying the system’s impact on nocturnal heartburn and regurgitation. Dr. Gabbard recently presented early results at the American College of Gastroenterology national conference.

An inclined sleep position decreases the chances of regurgitating  stomach acids into the esophagus by using gravity to separate the lower esophageal sphincter from where food and acid layer in the stomach. Left untreated, nocturnal GERD can lead to adenocarcinoma of the esophagus, Barrett’s esophagus, erosive esophagitis, esophageal ulcerations or peptic strictures.

Ten years ago, Cleveland Clinic also demonstrated that sleeping on the left side further separates the lower esophageal sphincter from the stomach – the problem is keeping patients on their left side at night.

Medcline, Amenity Health Inc. of San Diego, California, developed the Medcline sleep positioning device, consisting of wedge pillow with an arm insert, combined with a body positioning pillow. The system was originally studied in healthy volunteers and showed a significant decrease in reflux, as well as a 75 percent success rate in patents staying on their left side through the night.

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Dr. Gabbard wanted to know if similar results could be achieved in patients with nocturnal GERD who are on proton pump inhibitors. He enrolled nine patients with continued frequent moderate to severe nocturnal heartburn and regurgitation in a study using the sleep positioning device.  Patients completed the Nocturnal GERD Symptom Severity and Impact Questionnaire at enrollment, used the sleep assist device for two weeks, and then repeated the questionnaire.

The results show that the sleep positioning device significantly reduces nocturnal GERD symptoms, morning impact of GERD – waking up with chest burning, irritability and fatigue – and concern about nocturnal GERD.

“Patients were less concerned their GERD would cause long-term damage at night,” Dr. Gabbard says, adding that based on the results, he enrolled an additional 10 to 15 patients. “This clearly showed the system significantly improves symptoms of GERD, which is more valuable than learning that the system improves reflux in healthy volunteers.”

Dr. Gabbard says the ultimate goal is to determine if the device will decrease the need for prescription proton pump inhibitors, as well as prevent anti-reflux surgery for patients with severe symptoms.

“Anecdotally, a few patients interested in anti-reflux surgery had such a good response with the system that they were able to avoid having the surgery,” he says. “This therapy certainly is safer and more cost effective.”

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Dr. Gabbard and his colleagues are expanding the study of the sleep positioning system to patients with cough and throat burning at night, pregnant women and lung transplant patients.

“There are a lot of avenues this could be studied,” Dr. Gabbard says. “In our mind, the most important question to answer first was does this improve symptoms in patients, and it clearly does.”

For more information, please contact Dr. Gabbard at 216.444.6523 or gabbars@ccf.org.