Gezonde proefpersonen Healthy individuals
Conditions
Interventions
Participants will be randomly assigned to either the taVNS or sham stimulation 
group, administered 30 minutes before the MAST.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a significant reduction in the neuroendocrine stress response, measured by saliva cortisol samples, in the taVNS group compared to the sham treatment group following the MAST. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - Subjective stress responses to the MAST following taVNS or sham treatment, assessed through scores on the I-PANAS-SF and 0-100 Visual Analog Scales (VAS); - Autonomic response to stress following taVNS or sham treatment and the MAST, assessed using a combination of blood pressure monitoring, Fitbit smartwatch, and the Shimmer3 GSR sensor; - Stress responses in relation to potential affective symptoms and personality traits, using the GAD-7, PHQ-9, and BFI; - Number and severity of adverse events. | — |
Countries
Netherlands
Outcome results
None listed