[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648256":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Ohio State University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EmeTerm Wearable TENS Device","EXPERIMENTAL","Participants in this single-arm study will complete a 2-week baseline period during which they record daily gastrointestinal symptoms, including nausea. Participants who complete the baseline phase will receive the EmeTerm wearable transcutaneous electrical nerve stimulation (TENS) device and instructions for its use. During the 12-week treatment period, participants will use the device to help manage nausea while continuing to complete daily symptom diaries and weekly and monthly questionnaires. Study outcomes will compare symptom severity and other patient-reported measures during device use with those recorded during the baseline period.",[13],"Device: EmeTerm wearable TENS device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","EmeTerm wearable TENS device","EmeTerm wearable TENS device: A wrist-worn transcutaneous electrical nerve stimulation device that delivers low-frequency electrical stimulation to the median nerve to help control nausea and vomiting. Participants will use the device during a 12-week treatment period.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Subhankar CHAKRABORTY, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"SUBHANKAR CHAKRABORTY, M.D., Ph.D.","CONTACT","614-293-6255'","Subhankar.chakraborty@osumc.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Ohio State University Wexner Medical Center","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-82.99879,39.96118,{"lat":44,"lon":43},[47,50],{"name":48,"role":28,"phone":29,"phoneExt":20,"email":49},"Subhankar Chakraborty, MD, Ph.D.","subhankar.chakraborty@osumc.edu",{"name":48,"role":28,"phone":29,"phoneExt":20,"email":51},"subhankar2505206@yahoo.com",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100648256","evaluating-whether-a-nausea-band-reduces-symptoms-in-those-with-chronic-nausea-vomiting-100648256",false,"NCT07720323","Evaluating Whether a Nausea Band Reduces Symptoms in Those With Chronic Nausea Vomiting","Evaluating the Effect of a WearIng a TENS-device in NausEa Relief (The WINNER Study)","WINNER","Inclusion Criteria:\n\n* Nausea present for more than 2 months. Age 18 years or older. Able to understand English. Receiving care at The Ohio State University. Able to complete online surveys using a smartphone or computer\n\nExclusion Criteria:\n\n* Active treatment for cancer Current treatment for inflammatory bowel disease Cirrhosis End-stage renal disease Prior use of a wearable TENS unit for nausea Abdominal surgery within the previous 3 months Pregnancy (self-reported at enrollment) Current carpal tunnel syndrome Any contraindication to use of the EmeTerm device Inflammation, irritation, infection, ulceration, bleeding, open wounds, or other skin conditions near the wrist where the device is applied Presence of metallic implants in the body Head or facial injury within the previous 3 months Known brain tumor, meningitis, or stroke within the previous 3 months Cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device History of seizures","ALL","18 Years",{"count":65,"type":66},120,"ESTIMATED","INTERVENTIONAL",[69],"NA","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\\]\n\nThe main questions it aims to answer are:\n\nDoes 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\\]\n\nThis 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\\]\n\nParticipants will:\n\nComplete 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.",[72,73],"Chronic Nausea","Chronic Nausea and Vomiting Syndrome",[75,76,77,78,79,80,81,82,83,84],"chronic nausea","TENS","wearable device","median nerve stimulation","nausea and vomiting","gastroparesis","neuromodulation","quality of life","vomiting","appetite","2026-07-17",{"date":87,"type":88},"2026-07-22","ACTUAL",{"date":90,"type":88},"2023-02-01",{"date":92,"type":66},"2028-06-30",{"name":5,"class":6},1]