Exploring the Role of taVNS in Nausea Management

NCT07632456 | Recruiting

• 1 other identifier: NL88067.068.24
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Participants

Keywords

Vagal Nerve Stimulation; Nausea; Randomised Controlled Trial

Outcome Measures

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.

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)

Secondary Outcomes (9)

• Reduction in gastrointestinal symptoms

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)

• Changes in the desire to eat

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)

• Changes in ghrelin and motilin levels

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)

• Changes in salivary cortisol

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)

• Autonomic response: heart rate variability

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 3-4 hours)

Study Arms (2)

Transcutaneous Auricular Vagal Nerve Stimulation

ACTIVE COMPARATOR

Transcutaneous auricular vagal nerve stimulation, for 30 minutes

Device: Vagal Nerve Stimulation

Sham stimulation

PLACEBO COMPARATOR

Sham stimulation with a non-conducting electrode, for 30 minutes

Device: Sham stimulation

Interventions

Vagal Nerve Stimulation DEVICE

Transcutaneous Auricular Vagal Nerve Stimulation

Transcutaneous Auricular Vagal Nerve Stimulation

Sham stimulation DEVICE

Sham stimulation with a non-conducting electrode

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Keszthelyi: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

RECRUITING

MeSH Terms

Conditions

Nausea

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Daniel Keszthelyi, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fleur Veldman, MD

CONTACT

+31433884051; fleur.veldman@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Keszthelyi

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 8, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)