Exploring the Role of taVNS in Nausea Management
ConditionHealthy Adult Participants
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Vagal Nerve Stimulation
DeviceTranscutaneous Auricular Vagal Nerve Stimulation
Sham stimulation
DeviceSham stimulation with a non-conducting electrode
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Transcutaneous Auricular Vagal Nerve StimulationActive comparator 1 intervention
Group B: Sham stimulationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduction in nausea
A significant reduction in nausea in terms of intensity induced by intragastric lipid infusion following taVNS vs. sham treatment, assessed through 0-100 Visual Analogue Scales (0= not at all, 100=extremely; higher scores indicate greater nausea severity) at regular time intervals.
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)Secondary outcomes
1
Reduction in gastrointestinal symptoms
A significant reduction in gastrointestinal symptoms, including bloating, abdominal pain, and fullness following taVNS vs. sham stimulation after intragastric lipid infusion, assessed through 0-100 Visual Analog Scales (0=not at all, 100=extremely; higher scores indicate greater severity of gastrointestinal symptoms).
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)2
Changes in the desire to eat
Significant changes in the desire to eat following nausea induction after taVNS vs. sham stimulation, assessed through 0-100 Visual Analog Scales (0=not at all, 100=extremely; higher scores indicate greater desire to eat).
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)3
Changes in ghrelin and motilin levels
Significant changes in plasma ghrelin and motilin levels following taVNS vs. sham stimulation after nausea induction.
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)4
Changes in salivary cortisol
Significant changes in salivary cortisol levels following taVNS vs. sham stimulation after nausea induction.
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Daniel Keszthelyi
Lead sponsor
Academisch Ziekenhuis Maastricht
Sponsor institution
Source ClinicalTrials.gov