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

17 juli 2026 uppdaterad av: Ohio State University

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:

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: EmeTerm Wearable TENS Device
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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Average Weekly Frequency of Moderate to Severe Nausea
Tidsram: Baseline period (2 weeks) compared with the 12-week treatment period
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Frequency of Vomiting
Tidsram: Baseline period (2 weeks) compared with the 12-week treatment period.
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.
Change in Use of Anti-Nausea Medications
Tidsram: Baseline period (2 weeks) compared with the 12-week treatment period.
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
Baseline period (2 weeks) compared with the 12-week treatment period.

Samarbetspartners och utredare

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Sponsor

Ohio State University

Utredare

  • Huvudutredare: Subhankar CHAKRABORTY, MD, Ph.D., Ohio State University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2023

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

30 juni 2028

Studieregistreringsdatum

Först inskickad

17 juli 2026

Först inskickad som uppfyllde QC-kriterierna

17 juli 2026

Första postat (Faktisk)

22 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2022H0384

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Due to privacy concerns, Individual participant data will not be shared. There is no plan to make individual participant data available to external researchers.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

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