Exploring the Effect of taVNS on the Acute Stress Responses
1 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
60
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
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Limburg
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Maastricht, Limburg, Holandia, 6229ER
- Maastricht University
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Transcutaneous Auricular Vagal Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation, for 30 minutes
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Przezskórna stymulacja nerwu błędnego
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Komparator placebo: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Neuroendocrine stress response
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Subjective stress response
Ramy czasowe: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
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)
|
|
Cardiovascular stress response - blood pressure
Ramy czasowe: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
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
Ramy czasowe: 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)
|
|
Electrodermal stress response: skin conductance
Ramy czasowe: 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).
|
Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
|
Anxiety symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Daniel Keszthelyi, MD, PhD, Maastricht University Medical Center
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
21 marca 2025
Zakończenie podstawowe (Rzeczywisty)
12 marca 2026
Ukończenie studiów (Rzeczywisty)
12 marca 2026
Daty rejestracji na studia
Pierwszy przesłany
22 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
1 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
5 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NL87188.068.24
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .