Reletex for Nausea in GERD Patients
Reletex for Nausea in GERD Patients
Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently
 encountered in the health care setting. It affects roughly 40% of Americans monthly and 10%
 weekly. Of those with GERD, there exists a cohort that experience nausea with or without
 vomiting that is unresponsive to PPI's and anti-emetics. For these patients, treatment
 options are limited and these symptoms may substantially alter their quality of life. New and
 novel therapies emerging include neuromodulation devices that may affect the central pathways
 leading to these symptoms. Of these, the Reletex band has been tested and proven efficacious
 in the treatment of nausea and vomiting associated with pregnancy, chemotherapy, and surgery,
 in addition to standard anti-nausea medications. The investigators propose that through a
 similar mechanism, this device as an adjunct to PPI's and anti-emetics will reduce
 GERD-associated the nausea with or without vomiting, and by so doing, improve the quality of
 lives in this patient population.
Inclusion Criteria:

 -  Any patient over the age of 18 with clinically diagnosed GERD as evidenced by the
 GerdQ assessment tool and/or ambulatory pH/ pH- impedance monitoring with a component
 of nausea with or without vomiting.

 -  Continued symptoms despite a stable dose of FDA approved daily PPI therapy in addition
 to or without supportive anti-emetics. We will include patients with twice a day PPI
 dosing, as this is a standard treatment for PPI non-responders.

 -  Previous gastric emptying study performed as part of the standard care work-up of
 nausea and vomiting. Patients will be recruited regardless of the results and this
 information will only be used as a potential predictor for symptom response.

 Exclusion Criteria:

 -  Currently participating in a concurrent clinical trial or completed another trial
 within past 8 weeks.

 -  Prior gastrointestinal surgery of the esophagus and stomach.

 -  Severe esophagitis (Los Angeles esophagitis Grade C and above), Barrett's metaplasia
 or eosinophilic esophagitis, achalasia or spastic motor disorder

 -  Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with
 well-controlled hypertension, diabetes and a remote history of ischemic heart disease
 that is deemed stable, as judged by the physician-investigator can be included.
 Current drug or alcohol abuse or dependency.

 -  Current neurologic or cognitive illness or impairment which would make the patient an
 unsuitable candidate for hypnosis. This will be determined by the investigators before
 randomization using the Mini Mental Status Exam in patients with suspected impairment.

 -  Severe mental illness, e.g., uncontrolled major depression with suicidal ideation,
 active psychosis, diagnosis of schizophrenia-spectrum disorder.

 -  Those with nickel, gold, or other metal allergies.

 -  Those with other neuromodulators or implanted electrical devices such as cardiac
 pacemakers, AICD's, neurostimulators or transcutaneous electrical nerve stimulation
 devices (TENS units).

 -  Females who are or might become pregnant during the study.