Randomized Study of Different Nighttime Programming Methods for Enterra Therapy in Adults with Gastroparesis

What this Trial Is About

Researchers are evaluating different programming methods of the Enterra4 device during sleep to see if they can maintain relief from gastroparesis symptoms and improve quality of life. This study involves participants who already have an Enterra4 device implanted and aims to compare three different device settings during sleeping hours. The study is randomized and double-blinded, focusing on adult patients with gastroparesis aged 18 to 70 years. Participants will be assigned randomly to one of three groups one group will continue with their current device settings without changes during sleep, one will have a 6-hour cycle of reduced and waking-hour stimulation during sleep, and the other will have an 8-hour cycle with longer periods of reduced stimulation. During waking hours, all participants will use their usual device programming. The programming changes are within the approved labeling of the device. During the study, participants will use an app on their phone or tablet to answer daily questions about their gastroparesis symptoms and will complete quality of life questionnaires at study visits. Researchers will measure changes in vomiting frequency and nausea severity over three and six months. Participants will be involved for up to six months, with assessments including symptom tracking and quality of sleep evaluations to monitor the effects of the different device programming settings.

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics