Exploring the Effect of taVNS on the Acute Stress Responses
2026년 6월 1일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Limburg
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Maastricht, Limburg, 네덜란드, 6229ER
- Maastricht University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Transcutaneous Auricular Vagal Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation, for 30 minutes
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경피 귀의 미주 신경 자극
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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neuroendocrine stress response
기간: 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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective stress response
기간: 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
기간: 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
기간: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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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)
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Electrodermal stress response: skin conductance
기간: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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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
기간: 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
기간: Assessed once during the screening visit, prior to the experimental test day
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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
기간: Assessed once during the screening visit, prior to the experimental test day
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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
기간: 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
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Daniel Keszthelyi, MD, PhD, Maastricht University Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 3월 21일
기본 완료 (실제)
2026년 3월 12일
연구 완료 (실제)
2026년 3월 12일
연구 등록 날짜
최초 제출
2026년 5월 22일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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