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Exploring the Role of taVNS in Nausea Management

RecruitingNAAges 18 Years - 65 YearsAllDaniel Keszthelyi
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In plain words

What the trial is, and whether it could suit you

This single-center randomized controlled trial aims to investigate the efficacy of transcutaneous auricular vagus nerve stimulation in alleviating nausea in healthy adults. The primary aim of this study is to assess the efficacy of taVNS in reducing nausea in healthy adults subjected to nausea induction through intragastric lipid infusion, compared to sham stimulation, as measured by 0-100 Visual Analogue Scale (VAS) scores. The secondary objectives include evaluating the potential of taVNS to alleviate other gastrointestinal symptoms, such as abdominal pain, bloating, and fullness, as well as exploring its effects on the desire to eat, all measured using 0-100 VAS scores. Additionally, changes in autonomic parameters, plasma levels of ghrelin and motilin, and salivary cortisol will be evaluated. The relationship between the nausea response and affective symptoms, as well as personalit

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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: * 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.
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What it tests

  • Vagal Nerve Stimulation
  • Sham stimulation
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Where

1 site
Maastricht University
Maastricht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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