Study of External Upper Esophageal Sphincter Band to Reduce Nighttime Symptoms in Gastroesophageal Reflux Disease

What this Trial Is About

Gastroesophageal reflux disease GERD is a common condition affecting the esophagus and can cause symptoms beyond the esophagus, such as throat, airway, and lung problems. This research evaluates the use of an external upper esophageal sphincter UES band, known as the Shaker Pressure Band, to reduce nighttime symptoms caused by reflux into the throat. The study aims to better understand how increasing pressure at the UES might limit reflux and improve symptoms in patients with GERD who continue to experience symptoms despite medical treatment. Participants will use the Shaker Pressure Band device for one week, which applies external pressure at the level of the cricoid cartilage to increase UES pressure to 20 mmHg. The study is randomized and compares one week of active treatment with the band applying pressure against one week using a sham band that does not apply pressure. This design helps assess whether the external band can reduce reflux-related symptoms by limiting reflux into the throat. During the study, participants will undergo an initial physician assessment and symptom analysis after each treatment week to evaluate changes. Researchers will monitor subjective symptoms related to reflux, such as heartburn, cough, choking, and sleep disturbances. Participants will be followed for safety and symptom changes throughout the treatment periods. The total study duration includes one week of treatment with each band type and symptom assessments to measure the impact of the external band on reflux symptoms.

External UES Band (Shaker Pressure Band) and GERD