Evaluating Whether a Nausea Band Reduces Symptoms in Those With Chronic Nausea Vomiting (WINNER)
2026年7月17日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：SUBHANKAR CHAKRABORTY, M.D., Ph.D.
- 電話番号：614-293-6255'
- メール：Subhankar.chakraborty@osumc.edu
研究場所
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- 募集
- Ohio State University Wexner Medical Center
-
コンタクト：
- Subhankar Chakraborty, MD, Ph.D.
- 電話番号：614-293-6255'
- メール：subhankar.chakraborty@osumc.edu
-
コンタクト：
- Subhankar Chakraborty, MD, Ph.D.
- 電話番号：614-293-6255'
- メール：subhankar2505206@yahoo.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Average Weekly Frequency of Moderate to Severe Nausea
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Frequency of Vomiting
時間枠：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.
|
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Change in Use of Anti-Nausea Medications
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Subhankar CHAKRABORTY, MD, Ph.D.、Ohio State University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年2月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2028年6月30日
試験登録日
最初に提出
2026年7月17日
QC基準を満たした最初の提出物
2026年7月17日
最初の投稿 (実際)
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月17日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2022H0384
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Due to privacy concerns, Individual participant data will not be shared.
There is no plan to make individual participant data available to external researchers.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。