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NCT Number: NCT07341971

Effect of Non-invasive Vagal Nerve Stimulation on Selected Outcomes in Central Obesity

Trans Cutanous Electric Nerve Stimulation of Auricular Vagus Nerve

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutanous Auricular vagus nerve stimulation

Device

Non-invasive Auricular Vagus Stimulation

SHAM

Device

Non working device

Primary outcomes

  1. Change in serum Interleukin-6 (IL-6)

    Time frame: Baseline and after 4 weeks of intervention

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

Secondary outcomes

  1. Waist Circumference

    Time frame: Baseline and after 4 weeks of intervention

    Measurement of waist circumference in centimeters as an indicator of central adiposity

  2. Body Shape Index (ABSI)

    Time frame: Baseline and after 4 weeks of intervention

    Assessment of body shape using A Body Shape Index calculated from waist circumference, height, and weight.

  3. Depression Anxiety Stress Scale (DASS-21) Score

    Time frame: Baseline and after 4 weeks of intervention

    Evaluation of psychological status including depression, anxiety, and stress using the validated Depression Anxiety Stress Scale

    -21 questionnaire Higher scores indicate greater severity of emotional state The total score represents the sum of all 21 items multiplied by two. Sub scale scores for depression, anxiety and stress will be calculated and analyzed separately.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and after 4 weeks of intervention

    Assessment of sleep quality using the Pittsburgh Sleep Quality Index questionnaire.

    The total score ranges from 0 to 21 Score greater than 5 indicate poor sleep quality.

  5. Gut Feeling Questionnaire Score

    Time frame: Baseline and after 4 weeks of intervention

    Evaluation of gut-related symptoms and gut-brain interaction using a gut feeling questionnaire The total score is calculated by summing all questionnaire items, with higher scores indicating worse gut feelings.

Study contacts

Contact information is provided by the study sponsor or research team.

Lamiaa Z Salama, MSc

CONTACT

[email protected]

01099793264

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: NVN-CO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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