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Chronic NauseaWINNERNCT07720323

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

A study testing EmeTerm wearable TENS device in people with Chronic Nausea and Chronic Nausea and Vomiting Syndrome, run by Ohio State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EmeTerm wearable TENS device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Feb 2023to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

SUBHANKAR CHAKRABORTY, M.D., Ph.D. contact

614-293-6255'

Subhankar.chakraborty@osumc.edu

United States1 site, 1 recruiting
  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Subhankar Chakraborty, MD, Ph.D., 614-293-6255', subhankar.chakraborty@osumc.edu

    Subhankar Chakraborty, MD, Ph.D., 614-293-6255', subhankar2505206@yahoo.com

    Recruiting

Other trials in United States

About this study

Official title: Evaluating the Effect of a WearIng a TENS-device in NausEa Relief (The WINNER Study)

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:

Read more

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.

Read the detailed description

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.

Being tested
EmeTerm wearable TENS device
Keywords
chronic nausea, TENS, wearable device, median nerve stimulation, nausea and vomiting, gastroparesis, neuromodulation, quality of life, vomiting, appetite
Medical subject headings
Nausea, Vomiting, Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmeTerm wearable TENS deviceDevice

    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.

Study groups in NCT07720323
Study groupRoleWhat they receive
EmeTerm Wearable TENS DeviceExperimentalParticipants 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.
Receives: Device: EmeTerm wearable TENS device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline period (2 weeks) compared with the 12-week treatment period

Secondary outcomes (2)
  1. 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.

    Measured: Baseline period (2 weeks) compared with the 12-week treatment period.

  2. 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

    Measured: Baseline period (2 weeks) compared with the 12-week treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start1 Feb 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-group assignment study in which all eligible participants receive the EmeTerm wearable transcutaneous electrical nerve stimulation (TENS) device. Participants first complete a 2-week baseline observation period with daily symptom recording, followed by a 12-week treatment period using the device. Outcomes are evaluated by comparing symptoms and patient-reported measures collected during device use with those collected during the baseline period.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07720323
Sponsor's protocol ID
2022H0384
Acronym
WINNER
Status last verified
Jul 2026
First submitted
17 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
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.

Publications

  • 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/jnm16097.

    PubMed 28163260
  • 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/s0029-7844(03)00375-2.

    PubMed 12850618
  • 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/S2468-1253(17)30253-4. Epub 2017 Aug 18.

    PubMed 28826627
  • 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/j.appet.2021.105807. Epub 2021 Nov 17.

    PubMed 34798222
  • 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: 10.1097/00002820-199908000-00008.

    PubMed 10452208

Questions about this trial

What is this clinical trial studying?

A study testing EmeTerm wearable TENS device in people with Chronic Nausea and Chronic Nausea and Vomiting Syndrome, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SUBHANKAR CHAKRABORTY, M.D., Ph.D. (614-293-6255', Subhankar.chakraborty@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Average Weekly Frequency of Moderate to Severe Nausea (time frame: Baseline period (2 weeks) compared with the 12-week treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07720323, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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