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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| University of Ulster | OTHER |
| Exploristics | UNKNOWN |
| Compliance Solutions Ltd. |
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A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared to a sham control and a lifestyle modification program as a means of reducing excess body weight and body fat.
The purpose of this investigation device study is to collect data to support regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).
The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham control with both study arms incorporating a lifestyle modification program.
This protocol governs the activities at both the USA and NI/UK clinical sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VeSTAL - active device | Active Comparator | The VeSTAL device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. |
|
| Sham device | Sham Comparator | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VeSTAL | Device | The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change of Weight From Baseline | The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device | From baseline to 6 months |
| Categorical: Proportion of Participants Who Lose 5% Total Body Weight | The proportion of participants who lose 5% total body weight or more in the active Vestal group is at least 50%, independent of the sham control | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Loss of Baseline Visceral Adipose Tissue | The difference in mean percent loss of baseline visceral adipose tissue in the active versus placebo treated groups. (As measured by a whole body DXA scan). | % change in VAT mass at 6 months |
| Percentage Fat Loss |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Truncal Body Fat | This outcome measure assesses the amount of body fat located in the trunk or torso region at baseline. Truncal body fat includes both visceral and subcutaneous fat around the abdomen, chest, and back. It is typically measured using a whole-body DXA scan, which provides an accurate assessment of fat distribution. The baseline value is recorded before any intervention or treatment to serve as a reference point for evaluating changes in truncal body fat over the course of the study. |
Inclusion Criteria:
Exclusion Criteria:
If a subject is found to possibly have type 2 diabetes during the initial screening, then they will be excluded and asked to notify their primary care physician. However, if a subject passes the initial screening but a suspicion of this diagnosis arises during one of the study tests, then the subject will be asked to notify their primary care physician, though they will still be allowed to complete the study.
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| Name | Affiliation | Role |
|---|---|---|
| Erik Viirre, MD PhD | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego, Exercise and Physical Activity Resource Center | La Jolla | California | 92093 | United States | ||
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | VeSTAL - Active Device | The VeSTAL device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. |
| FG001 | Sham Device | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VeSTAL - Active Device | The VeSTAL device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change of Weight From Baseline | The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device | Unadjusted Intention to treat analysis | Posted | Mean | Standard Deviation | Percentage change from baseline | From baseline to 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VeSTAL - Active Device | The VeSTAL device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical and Regulatory | Neurovalens | 02890991835 | sinead.watson@neurovalens.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2021 | Apr 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2022 | Apr 26, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| INDUSTRY |
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|
Percentage fat loss from baseline. (As measured by means of a whole body DXA scan). |
| Percentage change from baseline to 6 months |
| Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group | Difference in lean muscle mass (in kilograms) in the active versus placebo treated group. (As measured by the whole body DXA scan). | Absolute change at 3 months and 6 months |
| Atherogenic Index | The Atherogenic Index is calculated using the lipid profile by determining the ratio of Total Cholesterol (TC) to High-Density Lipoprotein (HDL) cholesterol. If the ratio has been transformed (e.g., natural log-transformed or log10), this will be explicitly stated in the analysis, and the Unit of Measure will reflect this transformation as "log(ratio)" or "ln(ratio)" accordingly. | Absolute change from baseline to 6 months |
| Systemic Inflammation | Systemic inflammation is assessed using high-sensitivity C-reactive protein (hs-CRP) levels, measured in milligrams per liter (mg/L). This outcome measure represents the percentage change in hs-CRP levels from baseline to 6 months. Higher or lower percentage changes indicate increases or decreases in systemic inflammation, respectively. Values are reported as the mean percentage change with standard deviation (SD) for each group. | Percentage change from baseline to 6 months |
| Total Energy Intake (kcal) | Total Energy intake (kcal) as assessed by two-day 24 hour dietary recall. | Change from baseline to 6 months |
| Quality of Life Ratings | Quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, a validated self-report measure designed to assess obesity-specific quality of life in adults. Scores range from 0 to 100, with higher scores indicating better quality of life. The outcome measure reflects the absolute change in IWQOL-Lite total scores from baseline to 6 months (i.e., IWQOL-Lite score at 6 months minus IWQOL-Lite score at baseline). Results are reported as the mean absolute change with standard deviation for each study arm. | Absolute change from baseline to 6 months |
| Baseline |
| 6 Month Truncal Body Fat | This outcome measure assesses the amount of body fat located in the trunk or torso region at baseline. Truncal body fat includes both visceral and subcutaneous fat around the abdomen, chest, and back. It is typically measured using a whole-body DXA scan, which provides an accurate assessment of fat distribution. The baseline value is recorded before any intervention or treatment to serve as a reference point for evaluating changes in truncal body fat over the course of the study. | 6 Month |
| Difference in Bone Mineral Content | Bone mineral content (BMC) was measured to assess changes in bone health. The outcome reflects the absolute change in BMC from baseline to 6 months (i.e., BMC at 6 months minus BMC at baseline). Results are reported as the mean absolute change with standard deviation (SD) for each study arm. The Unit of Measure is BMC (kg), consistent with the reported data. Higher values indicate greater BMC, while lower or negative values indicate reductions in BMC over time. | Absolute change from baseline to 6 months |
| Fasting Glucose Change From Baseline | Fasting glucose in mg/dL | Change from Baseline to 6 months |
| Glycated Hemoglobin | This outcome measures the change in glycated hemoglobin (HbA1c) levels, reported as a percentage (%), from baseline to 6 months. HbA1c is a biomarker that reflects average blood glucose levels over the past 2-3 months and is commonly used to assess long-term glucose control. A reduction in HbA1c indicates improved blood sugar management. The change is calculated by subtracting the baseline value from the value at 6 months. | Change from baseline to 6 months Change from baseline to 6 months Change from baseline to 6 months |
| Blood Pressure | This outcome measures the change in diastolic blood pressure (measured in mmHg). Diastolic blood pressure was assessed using standard clinical methods at each time point. | Baseline |
| Blood Pressure | This outcome measures the change in diastolic blood pressure (measured in mmHg). Diastolic blood pressure was assessed using standard clinical methods at each time point. | 6 Months |
| Heart Rate | Heart rate in beats per minute | Baseline and 6 months |
| Hip-waist Ratio | Hip-waist ratio | 6 months |
| Body Mass Index (BMI) | BMI in kg/m^2 | Baseline and 6 months |
| Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | This outcome measure tracks the use of concomitant medications during the study, focusing on adjustments in cardiovascular medications and the presence of medications known to influence weight. For cardiovascular medications, data include any increases, decreases, or no changes in medication use, as well as instances where information is not applicable (N/A). The assessment also includes the categorization of medications known to cause weight gain or weight loss, reporting the number of participants using such medications. This allows for an understanding of how changes in cardiovascular treatments and the use of weight-altering medications may interact with study outcomes. | Baseline, Month 3, Month 6 (or other specified time points) |
| Dose Response Analysis | It is likely that some subjects will use their device more than other. Usage data will be available from the devices permitting a dose response analysis, which will done be in an intention to treat manner. Treatment Compliance =(Number of weeks with over 5 hours of total usage / Number weeks of device usage)*100 High Treatment Compliance = Treatment Compliance >75% Medium Treatment Compliance = Treatment Compliance >=55% and <=75% Low Treatment Compliance = Treatment Compliance <55% | Percentage Weight Loss from Baseline, by Treatment and Treatment Compliance at 3 months and 6 months |
| Hearing Loss Assessment | Hearing Loss (Judged to be abnormal, normal or missing by examining clinician by audiometry results). | Baseline and 6 months |
| Food Frequency Questionnaire | This outcome measure evaluates nutrient intake based on responses from the Food Frequency Questionnaire (FFQ). The FFQ assesses the frequency of consumption of various food items, allowing for an estimation of intake for several nutrients, including energy (kcal), carbohydrates (g), free sugars (g), total sugars (g), starch (g), fat (g), saturated fat (g), protein (g), fiber (g), and alcohol (g). Participants report their typical consumption of foods and beverages, which is then used to estimate their average intake of these nutrients over a specified period. The data are reported in grams or kilocalories, as appropriate for each nutrient, and can be used to evaluate dietary patterns and nutrient consumption changes throughout the study. | Baseline |
| Fat Intake | Fat intake as assessed by 24 hour dietary recall. | Baseline, 3-months and 6-months |
| Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall | Baseline, 3-months and 6-months |
| Fiber | Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire | Baseline, 3-months and 6-months |
| Alcohol | This outcome measure assesses alcohol consumption (in grams) based on a two-day, 24-hour dietary recall. Participants were asked to recall their alcohol intake for two separate 24-hour periods, providing a comprehensive estimate of their usual consumption. The data is presented for baseline, 3-month, and 6-month time points, with values reported as the mean and standard deviation (SD). | Baseline, 3-month, and 6-month |
| Healthy Eating Index | Nutrient intakes assessment from two-day 24-hour recall. Score out of 100 with a higher score reflecting a better quality of diet. | 6 months |
| Total Physical Activity in MET-hours Per Week | Total Physical Activity averaged over the past year in MET-hours per week as assessed by the Modifiable Activity Questionnaire | Baseline and 6 months |
| Saturated Fat Intake | Saturated fat intake as assessed by 24 hour dietary recall. | Baseline, 3-months and 6-months |
| University of California San Diego, Altman Clinical & Translational Research Institute, |
| La Jolla |
| California |
| 92093 |
| United States |
| Texas Diabetes and Endocrinology | Austin | Texas | 78749 | United States |
| Univeristy of Ulster | Coleraine | United Kingdom |
| Pregnancy |
|
| Withdrawal by Subject |
|
| Non-compliance |
|
| Medication change |
|
| Other |
|
| Joined another lifestyle program |
|
| BG001 | Sham Device | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Sham Device | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. |
|
|
| Primary | Categorical: Proportion of Participants Who Lose 5% Total Body Weight | The proportion of participants who lose 5% total body weight or more in the active Vestal group is at least 50%, independent of the sham control | Unadjusted Intention to treat analysis | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Mean Percent Loss of Baseline Visceral Adipose Tissue | The difference in mean percent loss of baseline visceral adipose tissue in the active versus placebo treated groups. (As measured by a whole body DXA scan). | Unadjusted Intention to treat | Posted | Mean | Standard Deviation | % change in VAT mass at 6 months | % change in VAT mass at 6 months |
|
|
|
| Secondary | Percentage Fat Loss | Percentage fat loss from baseline. (As measured by means of a whole body DXA scan). | Unadjusted Intention to Treat | Posted | Mean | Standard Deviation | Percentage change | Percentage change from baseline to 6 months |
|
|
|
| Secondary | Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group | Difference in lean muscle mass (in kilograms) in the active versus placebo treated group. (As measured by the whole body DXA scan). | ITT | Posted | Mean | Standard Deviation | Kg | Absolute change at 3 months and 6 months |
|
|
|
| Secondary | Atherogenic Index | The Atherogenic Index is calculated using the lipid profile by determining the ratio of Total Cholesterol (TC) to High-Density Lipoprotein (HDL) cholesterol. If the ratio has been transformed (e.g., natural log-transformed or log10), this will be explicitly stated in the analysis, and the Unit of Measure will reflect this transformation as "log(ratio)" or "ln(ratio)" accordingly. | Unadjusted Intention to Treat | Posted | Mean | Standard Deviation | Atherogenic Index | Absolute change from baseline to 6 months |
|
|
|
| Secondary | Systemic Inflammation | Systemic inflammation is assessed using high-sensitivity C-reactive protein (hs-CRP) levels, measured in milligrams per liter (mg/L). This outcome measure represents the percentage change in hs-CRP levels from baseline to 6 months. Higher or lower percentage changes indicate increases or decreases in systemic inflammation, respectively. Values are reported as the mean percentage change with standard deviation (SD) for each group. | Unadjusted Intention to Treat | Posted | Mean | Standard Deviation | % change mg/ml | Percentage change from baseline to 6 months |
|
|
|
| Secondary | Total Energy Intake (kcal) | Total Energy intake (kcal) as assessed by two-day 24 hour dietary recall. | Unadjusted | Posted | Mean | Standard Deviation | kcal | Change from baseline to 6 months |
|
|
|
| Secondary | Quality of Life Ratings | Quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, a validated self-report measure designed to assess obesity-specific quality of life in adults. Scores range from 0 to 100, with higher scores indicating better quality of life. The outcome measure reflects the absolute change in IWQOL-Lite total scores from baseline to 6 months (i.e., IWQOL-Lite score at 6 months minus IWQOL-Lite score at baseline). Results are reported as the mean absolute change with standard deviation for each study arm. | Adjusted Intention to Treat | Posted | Mean | Standard Deviation | IWQoL Total Score | Absolute change from baseline to 6 months |
|
|
|
| Other Pre-specified | Baseline Truncal Body Fat | This outcome measure assesses the amount of body fat located in the trunk or torso region at baseline. Truncal body fat includes both visceral and subcutaneous fat around the abdomen, chest, and back. It is typically measured using a whole-body DXA scan, which provides an accurate assessment of fat distribution. The baseline value is recorded before any intervention or treatment to serve as a reference point for evaluating changes in truncal body fat over the course of the study. | ITT | Posted | Mean | Standard Deviation | Kg | Baseline |
|
|
|
| Other Pre-specified | 6 Month Truncal Body Fat | This outcome measure assesses the amount of body fat located in the trunk or torso region at baseline. Truncal body fat includes both visceral and subcutaneous fat around the abdomen, chest, and back. It is typically measured using a whole-body DXA scan, which provides an accurate assessment of fat distribution. The baseline value is recorded before any intervention or treatment to serve as a reference point for evaluating changes in truncal body fat over the course of the study. | ITT | Posted | Mean | Standard Deviation | Kg | 6 Month |
|
|
|
| Other Pre-specified | Difference in Bone Mineral Content | Bone mineral content (BMC) was measured to assess changes in bone health. The outcome reflects the absolute change in BMC from baseline to 6 months (i.e., BMC at 6 months minus BMC at baseline). Results are reported as the mean absolute change with standard deviation (SD) for each study arm. The Unit of Measure is BMC (kg), consistent with the reported data. Higher values indicate greater BMC, while lower or negative values indicate reductions in BMC over time. | Unadjusted Intention to Treat | Posted | Mean | Standard Deviation | BMC (kg) | Absolute change from baseline to 6 months |
|
|
|
| Other Pre-specified | Fasting Glucose Change From Baseline | Fasting glucose in mg/dL | Safety Analysis Set | Posted | Mean | Standard Deviation | mg/dl | Change from Baseline to 6 months |
|
|
|
| Other Pre-specified | Glycated Hemoglobin | This outcome measures the change in glycated hemoglobin (HbA1c) levels, reported as a percentage (%), from baseline to 6 months. HbA1c is a biomarker that reflects average blood glucose levels over the past 2-3 months and is commonly used to assess long-term glucose control. A reduction in HbA1c indicates improved blood sugar management. The change is calculated by subtracting the baseline value from the value at 6 months. | Safety Analysis Set | Posted | Mean | Standard Deviation | percentage of HbA1c | Change from baseline to 6 months Change from baseline to 6 months Change from baseline to 6 months |
|
|
|
| Other Pre-specified | Blood Pressure | This outcome measures the change in diastolic blood pressure (measured in mmHg). Diastolic blood pressure was assessed using standard clinical methods at each time point. | Safety Analysis Set | Posted | Mean | Standard Deviation | mmHg | Baseline |
|
|
|
| Other Pre-specified | Blood Pressure | This outcome measures the change in diastolic blood pressure (measured in mmHg). Diastolic blood pressure was assessed using standard clinical methods at each time point. | Safety Analysis Set | Posted | Mean | Standard Deviation | mmHg | 6 Months |
|
|
|
| Other Pre-specified | Heart Rate | Heart rate in beats per minute | Safety Analysis Set | Posted | Mean | Standard Deviation | bpm | Baseline and 6 months |
|
|
|
| Other Pre-specified | Hip-waist Ratio | Hip-waist ratio | Data not analysed | Posted | 6 months |
|
|
| Other Pre-specified | Body Mass Index (BMI) | BMI in kg/m^2 | Safety Analysis Set | Posted | Mean | Standard Deviation | kg/m^2 | Baseline and 6 months |
|
|
|
| Other Pre-specified | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | This outcome measure tracks the use of concomitant medications during the study, focusing on adjustments in cardiovascular medications and the presence of medications known to influence weight. For cardiovascular medications, data include any increases, decreases, or no changes in medication use, as well as instances where information is not applicable (N/A). The assessment also includes the categorization of medications known to cause weight gain or weight loss, reporting the number of participants using such medications. This allows for an understanding of how changes in cardiovascular treatments and the use of weight-altering medications may interact with study outcomes. | ITT | Posted | Count of Participants | Participants | Baseline, Month 3, Month 6 (or other specified time points) |
|
|
|
| Other Pre-specified | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | This outcome measure tracks the use of concomitant medications during the study, focusing on adjustments in cardiovascular medications and the presence of medications known to influence weight. For cardiovascular medications, data include any increases, decreases, or no changes in medication use, as well as instances where information is not applicable (N/A). The assessment also includes the categorization of medications known to cause weight gain or weight loss, reporting the number of participants using such medications. This allows for an understanding of how changes in cardiovascular treatments and the use of weight-altering medications may interact with study outcomes. | ITT | Posted | Count of Participants | Participants | Baseline, Month 3, Month 6 (or other specified time points) |
|
|
|
| Other Pre-specified | Dose Response Analysis | It is likely that some subjects will use their device more than other. Usage data will be available from the devices permitting a dose response analysis, which will done be in an intention to treat manner. Treatment Compliance =(Number of weeks with over 5 hours of total usage / Number weeks of device usage)*100 High Treatment Compliance = Treatment Compliance >75% Medium Treatment Compliance = Treatment Compliance >=55% and <=75% Low Treatment Compliance = Treatment Compliance <55% | ITT | Posted | Mean | Standard Deviation | % weight loss | Percentage Weight Loss from Baseline, by Treatment and Treatment Compliance at 3 months and 6 months |
|
|
|
| Other Pre-specified | Hearing Loss Assessment | Hearing Loss (Judged to be abnormal, normal or missing by examining clinician by audiometry results). | Safety analysis set | Posted | Count of Participants | Participants | Baseline and 6 months |
|
|
|
| Other Pre-specified | Food Frequency Questionnaire | This outcome measure evaluates nutrient intake based on responses from the Food Frequency Questionnaire (FFQ). The FFQ assesses the frequency of consumption of various food items, allowing for an estimation of intake for several nutrients, including energy (kcal), carbohydrates (g), free sugars (g), total sugars (g), starch (g), fat (g), saturated fat (g), protein (g), fiber (g), and alcohol (g). Participants report their typical consumption of foods and beverages, which is then used to estimate their average intake of these nutrients over a specified period. The data are reported in grams or kilocalories, as appropriate for each nutrient, and can be used to evaluate dietary patterns and nutrient consumption changes throughout the study. | ITT | Posted | Mean | Standard Deviation | grams | Baseline |
|
|
|
| Other Pre-specified | Fat Intake | Fat intake as assessed by 24 hour dietary recall. | ITT | Posted | Mean | Standard Deviation | Fat (g) | Baseline, 3-months and 6-months |
|
|
|
| Other Pre-specified | Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall | ITT | Posted | Mean | Standard Deviation | grams | Baseline, 3-months and 6-months |
|
|
|
| Other Pre-specified | Fiber | Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire | ITT | Posted | Mean | Standard Deviation | grams | Baseline, 3-months and 6-months |
|
|
|
| Other Pre-specified | Alcohol | This outcome measure assesses alcohol consumption (in grams) based on a two-day, 24-hour dietary recall. Participants were asked to recall their alcohol intake for two separate 24-hour periods, providing a comprehensive estimate of their usual consumption. The data is presented for baseline, 3-month, and 6-month time points, with values reported as the mean and standard deviation (SD). | ITT | Posted | Mean | Standard Deviation | grams | Baseline, 3-month, and 6-month |
|
|
|
| Other Pre-specified | Healthy Eating Index | Nutrient intakes assessment from two-day 24-hour recall. Score out of 100 with a higher score reflecting a better quality of diet. | Not Posted | 6 months | Participants |
| Other Pre-specified | Total Physical Activity in MET-hours Per Week | Total Physical Activity averaged over the past year in MET-hours per week as assessed by the Modifiable Activity Questionnaire | ITT | Posted | Mean | Standard Deviation | MWET-hours/Week | Baseline and 6 months |
|
|
|
| Other Pre-specified | Saturated Fat Intake | Saturated fat intake as assessed by 24 hour dietary recall. | ITT | Posted | Mean | Standard Deviation | Saturated Fat (g) | Baseline, 3-months and 6-months |
|
|
|
| 0 |
| 116 |
| 0 |
| 116 |
| 52 |
| 116 |
| EG001 | Sham Device | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. | 0 | 122 | 0 | 122 | 56 | 122 |
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Mild Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| 6 months |
|
|
| 6 months |
|
|
| No change in cardiovascular medication |
|
| N/A |
|
| Not reported |
|
| Not reported |
|
| Month 3 Medium |
|
|
| Month 3 Low |
|
|
| Month 6 High |
|
|
| Month 6 Medium |
|
|
| Month 6 Low |
|
|
| Missing |
|
| Month 6 |
|
| Sugars |
|
| Starch |
|
| Fat |
|
| Saturated Fat |
|
| Protein |
|
| Fibre |
|
| Alcohol |
|
| Month 3 |
|
|
| Month 6 |
|
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| Month 3 |
|
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| Month 6 |
|
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| Month 3 |
|
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| Month 6 |
|
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| Month 3 |
|
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| Month 6 |
|
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| Month 6 |
|
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| Month 3 |
|
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| Month 6 |
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