- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07628842
Exploring the Effect of taVNS on the Acute Stress Responses
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Limburg
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Maastricht, Limburg, Países Bajos, 6229ER
- Maastricht University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Transcutaneous Auricular Vagal Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation, for 30 minutes
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Estimulación transcutánea del nervio vagal auricular
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Neuroendocrine stress response
Periodo de tiempo: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Subjective stress response
Periodo de tiempo: 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).
|
Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
|
Cardiovascular stress response - blood pressure
Periodo de tiempo: 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)
|
|
Autonomic stress response: heart rate variability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).
|
Assessed once during the screening visit, prior to the experimental test day
|
|
Depressive symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
|
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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Daniel Keszthelyi, MD, PhD, Maastricht University Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NL87188.068.24
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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