Electrical Vestibular Stimulation (VeNS): Assessment of AMPK & SIRT1 Following Repeated Usage
March 20, 2024 updated by: Neurovalens Ltd.
A Randomized, Double-blind, Sham-controlled Trial to Evaluate Changes in AMPK Following Daily Vestibular Nerve Stimulation (VeNS) in Adults Who Are Overweight or Obese.
The vestibular system which is responsible for balance and equilibrium constitutes our sixth sense.
Metabolic Syndrome is a constellation of metabolic abnormalities characterized by obesity, insulin resistance (diabetes mellitus), hypertension, and dyslipidemia.
It is generally agreed that a combination of three or more of the following components must be present: large waist circumference, elevated triglyceride, decreased high-density lipoprotein (HDL) cholesterol raised blood pressure, and elevated fasting blood sugar (FBS).
Sirtuin 1 (SIRT1) is one of seven mammalian orthologs of the yeast protein silent information regulator.
It is a conserved NAD-dependent protein deacetylase that decreases in cells that have high insulin resistance.
In vivo, insulin resistance and metabolic syndrome were associated with low SIRT1 gene and protein expression.
SIRT1 plays an important role to stimulate AMPK in improving mitochondrial function both in-vitro and in-vivo.
Adenosine 5'-monophosphate (AMP)-activated protein kinase (AMPK) is a key factor in regulating energy metabolism, placing it at the center stage in studies of diabetes and related metabolic disorders like metabolic syndrome.
It was reported that over a period of 6 weeks regular vestibular rehabilitation exercises caused an increase in the expression of SIRT1.
The sleep inducing effects of vestibular stimulation is well known.
Earlier studies reported improvement in the scores of Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) followed by the vestibular stimulation.
Hence, we hypothesize that vestibular stimulation will lead to up-regulation of both SIRT1 and AMPK.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madhya Pradesh
-
Ujjain, Madhya Pradesh, India, 456001
- RD Gardi Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Male and female participants 35-60 years of age group Metabolic syndrome (BMI 25-35 kg/m2) Type 2 Diabetes Hyperlipidemia Willing participants
Exclusion Criteria:
Using Beta blockers Ear problems ( assessed during physical examination) Under any kind of therapy or treatment With severe complications Vestibular disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group A: Healthy control group
Neither placebo nor vestibular stimulation is administered
|
|
|
Placebo Comparator: Group B: Placebo control group
Placebo stimulation along with regular treatment
|
Electrical vestibular nerve stimulation using a headset device
|
|
Active Comparator: Group C: Intervention group
Electrical vestibular nerve stimulation along with regular treatment
|
Electrical vestibular nerve stimulation using a headset device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of SIRT1 (Sirtuin 1)
Time Frame: 4 weeks
|
SIRT1 (Sirtuin 1) levels will be assessed from the blood samples by ELISA method using respective kits.
|
4 weeks
|
|
AMPK
Time Frame: 4 weeks
|
AMPK levels will be assessed from the blood samples by ELISA method using respective kits.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4 weeks
|
The Pittsburgh Sleep Quality Index (PSQI) is a standard questionnaire used to assess sleep quality and quantity for the last month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Minimum value = 0 Maximum value = 21 |
4 weeks
|
|
The Epworth Sleepiness Scale (ESS)
Time Frame: 4 weeks
|
The Epworth Sleepiness Scale (ESS) is a standard questionnaire used as a subjective measure of a patient's sleepiness. Minimum value = 0 Maximum value = 24 A higher score indicates worse outcome (excessive sleepiness) |
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
June 12, 2020
First Submitted That Met QC Criteria
June 12, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IVS002A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be transferred in an encrypted PDF format.
Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access.
Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF.
This PDF is generated on the fly and is therefore not stored in another location that could become compromised.
Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request.
These data will be transferred for each subject when they complete participation in the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.