An interventional study of EmeTerm wearable TENS device in Chronic Nausea and Chronic Nausea and Vomiting Syndrome, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Ohio State University · Not applicable, Interventional, and Supportive care
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.
644 studies on the registry are indexed under Nausea; 85 are open to participants now.
This study's planned enrollment of 120 is above the median of 96 across 544 interventional studies indexed under Nausea.
Browse Nausea studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: Baseline period (2 weeks) compared with the 12-week treatment period
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.
Time frame: Baseline period (2 weeks) compared with the 12-week treatment period.
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
Time frame: Baseline period (2 weeks) compared with the 12-week treatment period.
Plan to share: No — Due to privacy concerns, Individual participant data will not be shared. There is no plan to make individual participant data available to external researchers.
Started Feb 2023 (actual). Primary completion is estimated for Dec 2027, 58 months after the start.
Of 120 non-industry interventional studies with no phase under Nausea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 58 months is above that.
Counting every sponsor, half of 126 studies reached it within 13 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
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