NCT07720323 Evaluating Whether a Nausea Band Reduces Symptoms in Those With Chronic Nausea Vomiting
| NCT ID | NCT07720323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Chronic Nausea |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Subhankar CHAKRABORTY, MD, Ph.D.
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT07720323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Nausea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07720323 currently recruiting?
Yes, NCT07720323 is actively recruiting participants. Contact the research team at Subhankar.chakraborty@osumc.edu for enrollment information.
Where is the NCT07720323 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07720323 clinical trial?
NCT07720323 is sponsored by Ohio State University. The principal investigator is Subhankar CHAKRABORTY, MD, Ph.D. at Ohio State University. The trial plans to enroll 120 participants.