Healthy individuals Healthy individuals
Conditions
Interventions
Participants will be randomly assigned to either the taVNS or the sham 
stimulation group, with the intervention administered for 30 minutes 
immediately following nausea induction through intragastric lipid infusion.
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. - BMI between 18 and 25 kg/m2.
Exclusion criteria
Exclusion criteria: - Medical history of chronic or severe diseases 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. - A history of major abdominal surgery. - Gastrointestinal complaints. - Any use of medication, especially those affecting gastric motility and nausea, apart from oral contraceptives. - Current or lifetime psychopathology (including PHQ-9 and GAD-7 scores > 10) - Substance abuse, including excessive alcohol consumption (>20 alcoholic consumptions per week) and the use of recreational drugs. - Smoking. - Pregnancy, lactation, or intention to become pregnant during the study period. - Use of devices (e.g., cochlear implants) or other conditions (e.g. wounds, permanent ear-piercing) complicating the use of the tVNS device. - 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 nausea in terms of intensity and duration induced by intragastric lipid infusion following taVNS or sham treatment, assessed through 0-100 Visual Analogue Scales at regular time intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are: - Gastrointestinal symptoms, including bloating, abdominal pain, and fullness following taVNS or sham stimulation after intragastric lipid infusion, assessed through 0-100 VAS scales. - Changes in the desire to eat following nausea induction after taVNS or sham stimulation, assessed through 0-100 VAS scores. - Changes in plasma ghrelin and motilin levels following taVNS or sham stimulation after nausea induction. - Changes in salivary cortisol levels following taVNS or sham stimulation after nausea induction. - Nausea response in relation to affective symptoms and personality traits, assessed using the GAD-7, PHQ-9, and BFI questionnaires. - Autonomic response to nausea induction following taVNS or sham stimulation, measured using pulse plethysmography for heart rate and a Shimmer3 GSR sensor for heart rate variability (HRV) and skin conductance. | — |
Countries
Netherlands
Contacts
Public ContactF.H.C. Veldman
Universiteit Maastricht
Outcome results
None listed