Exploring the Role of taVNS in Nausea Management

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDaniel Keszthelyi

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vagal Nerve Stimulation
  • Sham stimulation

Treatment groups

35 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Daniel Keszthelyi

Lead sponsor

Academisch Ziekenhuis Maastricht

Sponsor institution