[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07720323":3,"trial-entities:NCT07720323":115,"trial-summary:NCT07720323":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":46,"secondary_outcomes":51,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":68,"locations":71,"central_contacts":89,"overall_officials":93,"references":97,"see_also_links":114},"NCT07720323","2022H0384","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)","RECRUITING","2028-06-30","2026-07","2026-07-22","2023-02-01","Ohio State University","OTHER",false,"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.","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.",[19,20],"Chronic Nausea","Chronic Nausea and Vomiting Syndrome",[22,23,24,25,26,27,28,29,30,31],"chronic nausea","TENS","wearable device","median nerve stimulation","nausea and vomiting","gastroparesis","neuromodulation","quality of life","vomiting","appetite","INTERVENTIONAL","SUPPORTIVE_CARE",[35],"NA",{"count":37,"type":38},120,"ESTIMATED",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44},"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.",[45],"EmeTerm Wearable TENS Device",[47],{"measure":48,"description":49,"timeFrame":50},"Change in Average Weekly Frequency of Moderate to Severe Nausea","Participants will complete a daily nausea diary during the baseline period and during the 12-week treatment period. Each day, participants will report whether they experienced nausea and rate its severity as no nausea, mild nausea, moderate nausea (required medication to control symptoms), or severe nausea (not responding to current medications). The outcome will be calculated as the average weekly frequency of days with moderate or severe nausea during the treatment period compared with the baseline period.","Baseline period (2 weeks) compared with the 12-week treatment period",[52,56],{"measure":53,"description":54,"timeFrame":55},"Change in Frequency of Vomiting","Participants will complete a daily symptom diary during the baseline period and the 12-week treatment period. Each day, participants will report whether they vomited and, if so, the number of vomiting episodes experienced that day (once, 2-3 times, or 4 or more times). The outcome measure will assess the change in average weekly frequency of vomiting episodes during use of the EmeTerm device compared with the baseline period before treatment.","Baseline period (2 weeks) compared with the 12-week treatment period.",{"measure":57,"description":58,"timeFrame":55},"Change in Use of Anti-Nausea Medications","Participants will complete a daily symptom diary during the baseline period and the 12-week treatment period. Each day, participants will report whether they used medications or other treatments to control nausea, including medications such as ondansetron, promethazine, prochlorperazine, granisetron, metoclopramide, erythromycin, domperidone, aprepitant, and other listed therapies. The outcome will assess the change in the frequency of anti-nausea medication use during treatment with the EmeTerm device compared with the baseline period","ALL","18 Years",null,{"inclusion":63,"exclusion":65,"raw_text":67},[64],"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",[66],"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","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",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":86},"Ohio State University Wexner Medical Center","Columbus","Ohio","43210","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Subhankar Chakraborty, MD, Ph.D.","CONTACT","614-293-6255'","subhankar.chakraborty@osumc.edu",{"name":80,"role":81,"phone":82,"email":85},"subhankar2505206@yahoo.com",{"lat":87,"lon":88},39.96118,-82.99879,[90],{"name":91,"role":81,"phone":82,"email":92},"SUBHANKAR CHAKRABORTY, M.D., Ph.D.","Subhankar.chakraborty@osumc.edu",[94],{"name":95,"affiliation":13,"role":96},"Subhankar CHAKRABORTY, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",[98,102,105,108,111],{"pmid":99,"type":100,"citation":101},"28163260","BACKGROUND","Sarosiek I, Song G, Sun Y, Sandoval H, Sands S, Chen J, McCallum RW. Central and Peripheral Effects of Transcutaneous Acupuncture Treatment for Nausea in Patients with Diabetic Gastroparesis. J Neurogastroenterol Motil. 2017 Apr 30;23(2):245-253. doi: 10.5056\u002Fjnm16097.",{"pmid":103,"type":100,"citation":104},"12850618","Rosen T, de Veciana M, Miller HS, Stewart L, Rebarber A, Slotnick RN. A randomized controlled trial of nerve stimulation for relief of nausea and vomiting in pregnancy. Obstet Gynecol. 2003 Jul;102(1):129-35. doi: 10.1016\u002Fs0029-7844(03)00375-2.",{"pmid":106,"type":100,"citation":107},"28826627","Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016\u002FS2468-1253(17)30253-4. Epub 2017 Aug 18.",{"pmid":109,"type":100,"citation":110},"34798222","Maharjan A, Peng M, Cakmak YO. The effects of frequency-specific, non-invasive, median nerve stimulation on food-related attention and appetite. Appetite. 2022 Feb 1;169:105807. doi: 10.1016\u002Fj.appet.2021.105807. Epub 2021 Nov 17.",{"pmid":112,"type":100,"citation":113},"10452208","Pearl ML, Fischer M, McCauley DL, Valea FA, Chalas E. Transcutaneous electrical nerve stimulation as an adjunct for controlling chemotherapy-induced nausea and vomiting in gynecologic oncology patients. Cancer Nurs. 1999 Aug;22(4):307-11. doi: 10.1097\u002F00002820-199908000-00008.",[],{"nct_id":4,"conditions":116,"biomarkers":119},[117,118],"Nausea","Vomiting",[],{"nct_id":4,"found":121,"summary":122,"prompt_version":131},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":37,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an interventional study planning to enroll 120 participants. It is being conducted at a single center.","completed","EmeTerm Device for Chronic Nausea and Vomiting","This study is testing if a wearable device called EmeTerm can help reduce chronic nausea and vomiting. The EmeTerm device is worn on the wrist and delivers low-frequency electrical stimulation to a nerve, which may help control nausea. Researchers want to see if using this device for 12 weeks reduces how often you experience moderate to severe nausea compared to your usual symptoms. They will also look at other symptoms like vomiting, abdominal pain, and how it affects your overall well-being. You might be able to join if you are 18 or older, have had nausea for over two months, can understand English, and receive care at The Ohio State University. The study is currently unclear about its recruitment status.","The primary outcome is measured at the end of the 12-week treatment period compared to a 2-week baseline period.","Participants will use the EmeTerm device for a 12-week treatment period. You will also need to complete online surveys using a smartphone or computer.","Not stated in the trial record.",[],"v2"]