ObesityNVN-CONCT07341971
Effect of Non-invasive Vagal Nerve Stimulation on Selected Outcomes in Central Obesity
A study testing Transcutanous Auricular vagus nerve stimulation in people with Obesity, run by Cairo University.
Trial summary
Trans Cutanous Electric Nerve Stimulation of Auricular Vagus Nerve Read more about this study
- Who is it for?
- Ages 25 to 35 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- Transcutanous Auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 25 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals with metabolic diseases
- Individuals taking cholesterol lowering drugs, Anti-hypertensive drugs, Oral-hypoglycemic drugs
- smokers
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Trans Cutanous Electric Nerve Stimulation of Auricular Vagus Nerve
- Conditions
- Obesity
- Being tested
- Transcutanous Auricular vagus nerve stimulation, Sham
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutanous Auricular vagus nerve stimulationDevice
Non-invasive Auricular Vagus Stimulation
ShamDevice
Non working device
| Study group | Role | What they receive |
|---|---|---|
| auricular vagus stimulation | Experimental | Transcutanous Electrial Nerve Stimulation Receives: Device: Transcutanous Auricular vagus nerve stimulation |
| Sham | Sham comparator | Sham Stimulation Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum Interleukin-6 (IL-6)
serum Interleukin-6 levels will be measured using (ELIZA)
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (5)
Waist Circumference
Measurement of waist circumference in centimeters as an indicator of central adiposity
Measured: Baseline and after 4 weeks of intervention
Body Shape Index (ABSI)
Assessment of body shape using A Body Shape Index calculated from waist circumference, height, and weight.
Measured: Baseline and after 4 weeks of intervention
Depression Anxiety Stress Scale (DASS-21) Score
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.
Measured: Baseline and after 4 weeks of intervention
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and after 4 weeks of intervention
Gut Feeling Questionnaire Score
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.
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion25 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Zakaria Abd El Salam Salama, Cairo University
- Investigators
- Nessreen G Al-Nahas, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341971
- Sponsor's protocol ID
- P.T.REC/012/006137
- Acronym
- NVN-CO
- Status last verified
- Oct 2025
- First submitted
- 6 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive Vagal Nerve Stimulation on Selected Outcomes in Central Obesity
- ClinicalTrials.gov ID
- NCT07341971
- Acronym / sponsor ID
- NVN-CO / P.T.REC/012/006137
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trans Cutanous Electric Nerve Stimulation of Auricular Vagus Nerve
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| auricular vagus stimulation | Experimental | Device: Transcutanous Auricular vagus nerve stimulationTranscutanous Electrial Nerve Stimulation |
| Sham | Sham comparator | Device: ShamSham Stimulation |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals with metabolic diseases
- Individuals taking cholesterol lowering drugs, Anti-hypertensive drugs, Oral-hypoglycemic drugs
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutanous Auricular vagus nerve stimulationNon-invasive Auricular Vagus Stimulation | Device | auricular vagus stimulation |
| ShamNon working device | Device | Sham |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nessreen G Al-Nahas, Professor principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Transcutanous Auricular vagus nerve stimulation in people with Obesity, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lamiaa Z Salama, MSc (01099793264, lamiasalama064@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum Interleukin-6 (IL-6) (time frame: Baseline and after 4 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.