Not yet recruiting NCT07341971
Effect of Non-invasive Vagal Nerve Stimulation on Selected Outcomes in Central Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutanous Auricular vagus nerve stimulation, Sham.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 25 years — 35 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Trans Cutanous Electric Nerve Stimulation of Auricular Vagus Nerve
Interventions
- Device Transcutanous Auricular vagus nerve stimulation
Non-invasive Auricular Vagus Stimulation - Device Sham
Non working device
Primary outcome measures
- Change in serum Interleukin-6 (IL-6) [Time frame: Baseline and after 4 weeks of intervention]
Secondary outcome measures (5)
- Waist Circumference [Time frame: Baseline and after 4 weeks of intervention]
- Body Shape Index (ABSI) [Time frame: Baseline and after 4 weeks of intervention]
- Depression Anxiety Stress Scale (DASS-21) Score [Time frame: Baseline and after 4 weeks of intervention]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and after 4 weeks of intervention]
- Gut Feeling Questionnaire Score [Time frame: Baseline and after 4 weeks of intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Individuals with metabolic diseases
- Individuals taking cholesterol lowering drugs, Anti-hypertensive drugs, Oral-hypoglycemic drugs
- smokers
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07341971 · P.T.REC/012/006137