How Does Vagus Nerve Stimulation Affect Blood Glucose, Fo... | NCT07457372

Studies
How Does Vagus Nerve Stimulation Affect Blood Glucose, Food, and Movement Cravings?

NCT07457372

Sponsor

University of Minnesota

Status

Not yet recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

8Estimated

Phase

Not Applicable

Conditions

Vagus Nerve Stimulation

Interventions

Active taVNS
Sham taVNS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

May 1, 2028Estimated

Completion Date

May 1, 2028Estimated

First Submitted Date

Mar 3, 2026

First Submission Date that Met QC Criteria

Mar 3, 2026

First Posted Date

Mar 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the feasibility of using non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) to examine physiological and psychological responses in a college-aged healthy population

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active taVNS	Active Comparator		Device: Active taVNS
Sham taVNS	Placebo Comparator		Device: Sham taVNS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active taVNS	Device	Actual taVNS	Active taVNS
Sham taVNS

Measure	Description	Time Frame
Change in plasma glucose		Hour 2 after oral glucose load

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be between the ages of 18 and 35 as we are focused on recruiting undergraduate and graduate students.

Exclusion Criteria:

Participants will be excluded if they have epilepsy, clinically significant tachycardia or arrhythmia, diabetes (Type 1 or Type 2) or another metabolic disease, current pregnancy, any implanted electronic medical device (for example, pacemaker or defibrillator), or a known skin allergy to adhesives that would prevent CGM placement. Participants will also be excluded if they have a history of major depressive disorder if taVNS could reasonably be expected to alter mood symptoms

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mark Hartman, PhD	Contact	218-726-7275		hartm373@d.umn.edu

Overall Officials

Name	Affiliation	Role
Mark Hartman, PhD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota Duluth		Duluth	Minnesota	55812	United States