NCT07632456 Exploring the Role of taVNS in Nausea Management
| NCT ID | NCT07632456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daniel Keszthelyi |
| Condition | Healthy Adult Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2025-12-08 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 personality traits, will also be explored. 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.
Eligibility 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: * 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.
Contact & Investigator
Daniel Keszthelyi, MD, PhD
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center
Frequently Asked Questions
Who can join the NCT07632456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Adult Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07632456 currently recruiting?
Yes, NCT07632456 is actively recruiting participants. Contact the research team at fleur.veldman@maastrichtuniversity.nl for enrollment information.
Where is the NCT07632456 trial being conducted?
This trial is being conducted at Maastricht, Netherlands.
Who is sponsoring the NCT07632456 clinical trial?
NCT07632456 is sponsored by Daniel Keszthelyi. The principal investigator is Daniel Keszthelyi, MD, PhD at Maastricht University Medical Center. The trial plans to enroll 35 participants.