Exploring the Effect of taVNS on the Acute Stress Responses
2026年6月1日 更新者：Daniel Keszthelyi
Exploring the effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on the Acute Stress Responses: a Double-blind Randomized Controlled Trial
This single-center randomized controlled trial aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on the acute stress responses.
The primary aim of this study is to assess the efficacy of taVNS in mitigating the acute stress response induced by the Maastricht Acute Stress Task (MAST) among healthy subjects, measured by cortisol levels in saliva samples.
Secondary objectives include:
- Evaluating taVNS's potential to counteract stress-induced sympathetic activation and thereby alleviate stress-related effects, including negative affect, as measuring using the I-PANAS-SF questionnaire, and feelings of stress, pain, and unpleasantness, as measured with 0-100 Visual Analog Scales (VAS)
- Assessing its impact on autonomic outflow parameters, using a blood pressure monitor for blood pressure, and a FitBit smartwatch for heart rate variability, and Shimmer3 GSR sensor for heart rate variability and skin conductance.
- Evaluating the relationship between stress responses and affective symptoms and personality traits, utilizing the Generalized Anxiety Disorder 7-Item Scale (GAD-7), Patient Health Questionnaire (PHQ-9), and the Big Five Inventory (BFI).
Participants will be randomly assigned to either the taVNS or sham stimulation group, administered 30 minutes before the MAST.
調査の概要
研究の種類
介入
入学 (実際)
60
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。
研究場所
-
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Limburg
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Maastricht、Limburg、オランダ、6229ER
- Maastricht University
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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
はい
説明
Inclusion Criteria:
- Healthy participants (defined as those without a pre-existing medical comorbidity)
- Aged between 18-65 years
- Ability to understand and speak the Dutch language.
Exclusion Criteria:
- Medical history or condition affecting the cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, haematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric systems, as well as prior major surgeries or ongoing laboratory abnormalities that could potentially limit participation or completion of the study protocol;
- Any use of medication, especially those that may influence the autonomic nervous system or the hypothalamus-pituitary-adrenal axis (e.g., beta-agonists or corticosteroids), with the exception of contraceptives and paracetamol;
- Current or lifetime psychopathology (including PHQ-9 and GHD-7 scores > 10);
- Substance abuse (including excessive alcohol consumption);
- Smoking;
- Pregnancy, lactation, or intention to become pregnant during the study period;
- Use of devices (e.g., cochlear implants) or other reasons (e.g. wounds, permanent ear-piercing) which complicate the use of the tVNS device;
- Participation in another clinical study in which the MAST was used;
- Administration of investigational drugs or participation in any scientific intervention study that might interfere with this study (to be determined by the principal investigator) within 180 days preceding the commencement of the study;
- Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department.
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Transcutaneous Auricular Vagal Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation, for 30 minutes
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経皮的耳介迷走神経刺激
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プラセボコンパレーター：Sham stimulation
Sham stimulation with a non-conducting electrode, for 30 minutes
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Sham stimulation with a non-conducting electrode
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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 |
|---|---|---|
|
Neuroendocrine stress response
時間枠：Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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A significant reduction in the neuroendocrine stress response triggered by the MAST following taVNS or sham treatment, assessed through saliva cortisol samples, with a defined threshold of a 35% decrease.
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Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Subjective stress response
時間枠：Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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Subjective stress responses to the MAST following taVNS or sham treatment, assessed using the negative affect subscale of the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF; total score range: 5-25, with higher scores indicating greater negative affect) and 0-100 Visual Analog Scales (VAS) for stress, pain, and unpleasantness (0=not at all, 100=extremely; higher scores indicate greater perceived stress, pain, or unpleasantness).
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Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
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Cardiovascular stress response - blood pressure
時間枠：Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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Changes in systolic and diastolic blood pressure responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed in mmHg.
Blood pressure was measured four times.
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Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
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Autonomic stress response: heart rate variability
時間枠：Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
Changes in heart rate variability responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed using Fitbit and Shimmer3 GSR.
Heart rate variability was measured continuously during the test day.
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Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
|
Electrodermal stress response: skin conductance
時間枠：Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
Changes in skin conductance responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed in microsiemens (µS).
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Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
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Anxiety symptoms
時間枠：Assessed once during the screening visit, prior to the experimental test day
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Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 questionnaire (GAD-7; total score range: 0-21, with higher scores indicating greater anxiety symptom severity).
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Assessed once during the screening visit, prior to the experimental test day
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Depressive symptoms
時間枠：Assessed once during the screening visit, prior to the experimental test day
|
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9; total score range: 0-27, with higher scores indicating greater depressive symptom severity).
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Assessed once during the screening visit, prior to the experimental test day
|
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Personality traits
時間枠：Assessed once during the screening visit, prior to the experimental test day
|
Personality traits assessed using the Big Five Inventory-44 (BFI-44).
The BFI-44 measures five personality domains (Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness to Experience).
Each domain score is computed as a sum or mean of item responses on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with higher scores indicating greater expression of the respective personality trait.
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Assessed once during the screening visit, prior to the experimental test day
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Adverse events
時間枠：Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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Number and severity of adverse events
|
Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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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：Daniel Keszthelyi, MD, PhD、Maastricht University Medical Center
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)
2025年3月21日
一次修了 (実際)
2026年3月12日
研究の完了 (実際)
2026年3月12日
試験登録日
最初に提出
2026年5月22日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月5日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
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。