taVNS for nausea in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center randomized trial enrolls healthy adults aged 18–65 to receive taVNS or sham stimulation after nausea is induced by intragastric lipid infusion. Primary outcome is nausea intensity on a 0–100 scale; secondary outcomes include abdominal symptoms, appetite desire, autonomic measures, and plasma/ salivary biomarkers. Participants complete screening questionnaires and are randomized 1:1 with blinding maintained for the test day. The study uses Castor for data capture and follows standard ethical procedures for consent and safety monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Maastricht University
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Principal investigator: Daniel Keszthelyi, MD, PhD — Maastricht University Medical Center
• Study coordinator: Fleur Veldman, MD
• Email: fleur.veldman@maastrichtuniversity.nl
• Phone: +31433884051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.