Evaluating Whether a Nausea Band Reduces Symptoms in Those With Chronic Nausea Vomiting

Overview

The goal of this clinical trial is to learn whether a wearable transcutaneous electrical nerve stimulation (TENS) device called EmeTerm can help reduce nausea in adults who have had nausea for 2 months or longer and who receive care at The Ohio State University. The study will also evaluate whether use of the device affects other symptoms and aspects of wellbeing, including vomiting, abdominal pain, bloating, constipation, appetite, sleep, mood, stress, fatigue, quality of life, and hope. \[34\_Emeterm...rotocol\_v3 \| Word\] The main questions it aims to answer are: Does using the EmeTerm device reduce the average weekly frequency of moderate to severe nausea compared with symptoms during a baseline observation period? \[34\_Emeterm...rotocol\_v3 \| Word\] Does using the EmeTerm device reduce the duration of nausea, frequency of vomiting, and use of anti-nausea medications, and improve other gastrointestinal symptoms, wellbeing, and quality of life? \[34\_Emeterm...rotocol\_v3 \| Word\] This is a single-arm study. Participants will serve as their own comparison by comparing symptoms during device use with symptoms recorded during the baseline period before using the device. \[34\_Emeterm...rotocol\_v3 \| Word\] Participants will: Complete a screening survey and provide electronic informed consent if eligible. \[34\_Emeterm...rotocol\_v3 \| Word\] Complete baseline questionnaires and record daily gastrointestinal symptoms for a 2-week baseline period. \[34\_Emeterm...rotocol\_v3 \| Word\] Receive an EmeTerm wearable TENS device and instructions for its use. \[34\_Emeterm...rotocol\_v3 \| Word\] Use the EmeTerm device for 12 weeks while continuing to record nausea and other gastrointestinal symptoms. \[34\_Emeterm...rotocol\_v3 \| Word\] Complete weekly and monthly surveys about symptoms, stress, sleep, appetite, fatigue, quality of life, anxiety, depression, autonomic symptoms, device experience, and any adverse events.

Chronic nausea with or without vomiting is a debilitating condition that may be associated with symptoms such as bloating, early satiety, abdominal pain, and constipation. Management of chronic nausea can be challenging, and additional non-pharmacologic treatment options are needed. The EmeTerm device is a wearable transcutaneous electrical nerve stimulation (TENS) unit that stimulates the median nerve at the wrist. The stimulation is believed to influence signaling pathways involved in nausea and may reduce nausea sensations. The device has received FDA 510(k) clearance for the control of nausea and vomiting caused by motion sickness and pregnancy. \[34\_Emeterm...rotocol\_v3 \| Word\] The WINNER (WearINg a TENS-device in Nausea Relief) Study is a single-center clinical trial conducted at The Ohio State University to evaluate the effectiveness of the EmeTerm wearable TENS device in adults with nausea that has persisted for more than 2 months. The primary objective is to determine whether use of the device reduces the frequency of moderate-to-severe nausea compared with a baseline observation period. Secondary objectives include evaluating changes in nausea duration, vomiting frequency, use of anti-nausea medications, gastrointestinal symptoms, appetite, sleep, fatigue, stress, mood, quality of life, autonomic symptoms, and hope. \[34\_Emeterm...rotocol\_v3 \| Word\] Participants who meet eligibility criteria will first complete baseline assessments and record daily gastrointestinal symptoms during a 2-week baseline period. Participants who successfully complete the baseline phase will receive the EmeTerm device and enter a 12-week treatment period. During the treatment phase, participants will use the device as instructed while continuing to complete symptom diaries and study questionnaires. Outcomes will be assessed by comparing symptom measures collected during device use with those collected during the baseline period. Participant safety will be monitored through weekly adverse-event questionnaires and participant reporting of any side effects. \[34\_Emeterm...rotocol\_v3 \| Word\] The study plans to have approximately 120 participants receive the device and complete the treatment phase.