NCT07341971

Brief Summary

Trans Cutanous Electric Nerve Stimulation of Auricular Vagus Nerve

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable obesity

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2026May 2026

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2026

Last Updated

March 3, 2026

Status Verified

October 1, 2025

Enrollment Period

3 months

First QC Date

January 6, 2026

Last Update Submit

February 28, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in serum Interleukin-6 (IL-6)

    serum Interleukin-6 levels will be measured using (ELIZA)

    Baseline and after 4 weeks of intervention

Secondary Outcomes (5)

  • Waist Circumference

    Baseline and after 4 weeks of intervention

  • Body Shape Index (ABSI)

    Baseline and after 4 weeks of intervention

  • Depression Anxiety Stress Scale (DASS-21) Score

    Baseline and after 4 weeks of intervention

  • Pittsburgh Sleep Quality Index (PSQI)

    Baseline and after 4 weeks of intervention

  • Gut Feeling Questionnaire Score

    Baseline and after 4 weeks of intervention

Study Arms (2)

auricular vagus stimulation

EXPERIMENTAL

Transcutanous Electrial Nerve Stimulation

Device: Transcutanous Auricular vagus nerve stimulation

Sham

SHAM COMPARATOR

Sham Stimulation

Device: Sham

Interventions

Transcutanous Auricular vagus nerve stimulationDEVICE

Non-invasive Auricular Vagus Stimulation

auricular vagus stimulation
ShamDEVICE

Non working device

Sham

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sixty male
  • Age ranges from 25 to 35
  • All them are medically stable with no chronic disease
  • waist circumference more than 94
  • Body Mass Index more than or equal 30

You may not qualify if:

  • Individuals with metabolic diseases
  • Individuals taking cholesterol lowering drugs, Anti-hypertensive drugs, Oral-hypoglycemic drugs
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nessreen G Al-Nahas, Professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lamiaa Z Salama, MSc

CONTACT

01099793264lamiasalama064@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Faculty of physical Therapy

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

May 25, 2026

Last Updated

March 3, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared