Trial Outcomes & Findings for Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial (NCT NCT03640286)

NCT ID: NCT03640286

Last Updated: 2025-03-12

Results Overview

The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 241 participants
• Primary outcome timeframe: From baseline to 6 months
• Results posted on: 2025-03-12

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	117	124
Overall Study COMPLETED	91	89
Overall Study NOT COMPLETED	26	35

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	6	6
Overall Study Lost to Follow-up	3	6
Overall Study Pregnancy	1	0
Overall Study Withdrawal by Subject	10	10
Overall Study Non-compliance	4	10
Overall Study Medication change	1	0
Overall Study Other	1	2
Overall Study Joined another lifestyle program	0	1

Baseline Characteristics

Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial

Baseline characteristics by cohort

Measure	VeSTAL - Active Device n=117 Participants 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.	Sham Device n=124 Participants 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.	Total n=241 Participants Total of all reporting groups
Age, Continuous	45.5 years STANDARD_DEVIATION 12.3 • n=5 Participants	47.2 years STANDARD_DEVIATION 10.8 • n=7 Participants	46.3 years STANDARD_DEVIATION 11.53 • n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	99 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	25 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	95 Participants n=7 Participants	189 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants	76 participants n=7 Participants	147 participants n=5 Participants
Region of Enrollment United Kingdom	46 participants n=5 Participants	48 participants n=7 Participants	94 participants n=5 Participants
Weight	99.60 Kg STANDARD_DEVIATION 20.07 • n=5 Participants	99.86 Kg STANDARD_DEVIATION 20.37 • n=7 Participants	99.73 Kg STANDARD_DEVIATION 20.18 • n=5 Participants
Body Mass Index	36.94 kg/m^2 STANDARD_DEVIATION 6.65 • n=5 Participants	35.81 kg/m^2 STANDARD_DEVIATION 5.76 • n=7 Participants	36.36 kg/m^2 STANDARD_DEVIATION 6.22 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 6 months

Population: Unadjusted Intention to treat analysis

The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device

Outcome measures

Measure	VeSTAL - Active Device n=91 Participants 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.	Sham Device n=90 Participants 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.
Percentage Change of Weight From Baseline	-2.46 Percentage change from baseline Standard Deviation 4.766	-1.97 Percentage change from baseline Standard Deviation 4.971

PRIMARY outcome

Timeframe: 6 months

Population: Unadjusted Intention to treat analysis

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

Outcome measures

Measure	VeSTAL - Active Device n=117 Participants 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.	Sham Device n=124 Participants 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.
Categorical: Proportion of Participants Who Lose 5% Total Body Weight	25 Participants	25 Participants

SECONDARY outcome

Timeframe: % change in VAT mass at 6 months

Population: Unadjusted Intention to treat

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).

Outcome measures

Measure	VeSTAL - Active Device n=54 Participants 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.	Sham Device n=58 Participants 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.
Mean Percent Loss of Baseline Visceral Adipose Tissue	-10.316 % change in VAT mass at 6 months Standard Deviation 12.4607	-4.731 % change in VAT mass at 6 months Standard Deviation 14.6057

SECONDARY outcome

Timeframe: Percentage change from baseline to 6 months

Population: Unadjusted Intention to Treat

Percentage fat loss from baseline. (As measured by means of a whole body DXA scan).

Outcome measures

Measure	VeSTAL - Active Device n=60 Participants 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.	Sham Device n=58 Participants 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.
Percentage Fat Loss	-5.268 Percentage change Standard Deviation 8.1254	-3.638 Percentage change Standard Deviation 9.1772

SECONDARY outcome

Timeframe: Absolute change at 3 months and 6 months

Population: ITT

Difference in lean muscle mass (in kilograms) in the active versus placebo treated group. (As measured by the whole body DXA scan).

Outcome measures

Measure	VeSTAL - Active Device n=9 Participants 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.	Sham Device n=8 Participants 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.
Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group 3 months	-0.107 Kg Standard Deviation 2.1676	0.990 Kg Standard Deviation 1.3227
Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group 6 months	-0.169 Kg Standard Deviation 1.9577	-0.078 Kg Standard Deviation 1.8110

SECONDARY outcome

Timeframe: Absolute change from baseline to 6 months

Population: Unadjusted Intention to Treat

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.

Outcome measures

Measure	VeSTAL - Active Device n=55 Participants 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.	Sham Device n=55 Participants 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.
Atherogenic Index	-0.10 Atherogenic Index Standard Deviation 0.660	-0.27 Atherogenic Index Standard Deviation 0.454

SECONDARY outcome

Timeframe: Percentage change from baseline to 6 months

Population: Unadjusted Intention to Treat

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.

Outcome measures

Measure	VeSTAL - Active Device n=57 Participants 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.	Sham Device n=56 Participants 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.
Systemic Inflammation	-0.51 % change mg/ml Standard Deviation 5.645	-0.31 % change mg/ml Standard Deviation 1.845

SECONDARY outcome

Timeframe: Change from baseline to 6 months

Population: Unadjusted

Total Energy intake (kcal) as assessed by two-day 24 hour dietary recall.

Outcome measures

Measure	VeSTAL - Active Device n=82 Participants 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.	Sham Device n=85 Participants 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.
Total Energy Intake (kcal)	-241.56 kcal Standard Deviation 703.820	-180.39 kcal Standard Deviation 1114.909

SECONDARY outcome

Timeframe: Absolute change from baseline to 6 months

Population: Adjusted Intention to Treat

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.

Outcome measures

Measure	VeSTAL - Active Device n=88 Participants 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.	Sham Device n=89 Participants 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.
Quality of Life Ratings	7.71 IWQoL Total Score Standard Deviation 12.193	9.08 IWQoL Total Score Standard Deviation 14.022

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: ITT

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.

Outcome measures

Measure	VeSTAL - Active Device n=117 Participants 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.	Sham Device n=124 Participants 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.
Baseline Truncal Body Fat	25.209 Kg Standard Deviation 8.4520	24.393 Kg Standard Deviation 7.4186

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Month

Population: ITT

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.

Outcome measures

Measure	VeSTAL - Active Device n=10 Participants 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.	Sham Device n=8 Participants 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.
6 Month Truncal Body Fat	19.082 Kg Standard Deviation 4.1085	20.008 Kg Standard Deviation 4.5043

OTHER_PRE_SPECIFIED outcome

Timeframe: Absolute change from baseline to 6 months

Population: Unadjusted Intention to Treat

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.

Outcome measures

Measure	VeSTAL - Active Device n=60 Participants 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.	Sham Device n=58 Participants 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.
Difference in Bone Mineral Content	0.003 BMC (kg) Standard Deviation 0.0645	-0.001 BMC (kg) Standard Deviation 0.0504

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 6 months

Population: Safety Analysis Set

Fasting glucose in mg/dL

Outcome measures

Measure	VeSTAL - Active Device n=55 Participants 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.	Sham Device n=56 Participants 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.
Fasting Glucose Change From Baseline	0.798 mg/dl Standard Deviation 10.9941	0.164 mg/dl Standard Deviation 6.8325

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 6 months Change from baseline to 6 months Change from baseline to 6 months

Population: Safety Analysis Set

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.

Outcome measures

Measure	VeSTAL - Active Device n=56 Participants 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.	Sham Device n=56 Participants 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.
Glycated Hemoglobin	-0.148 percentage of HbA1c Standard Deviation 0.8657	-0.004 percentage of HbA1c Standard Deviation 0.2166

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Safety Analysis Set

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.

Outcome measures

Measure	VeSTAL - Active Device n=115 Participants 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.	Sham Device n=119 Participants 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.
Blood Pressure	85.4 mmHg Standard Deviation 11.07	82.0 mmHg Standard Deviation 10.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Safety Analysis Set

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.

Outcome measures

Measure	VeSTAL - Active Device n=59 Participants 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.	Sham Device n=58 Participants 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.
Blood Pressure	85.6 mmHg Standard Deviation 11.46	81.3 mmHg Standard Deviation 8.89

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Population: Safety Analysis Set

Heart rate in beats per minute

Outcome measures

Measure	VeSTAL - Active Device n=115 Participants 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.	Sham Device n=119 Participants 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.
Heart Rate Baseline	70.8 bpm Standard Deviation 9.99	69.6 bpm Standard Deviation 10.14
Heart Rate 6 months	71.1 bpm Standard Deviation 10.29	68.6 bpm Standard Deviation 10.66

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Data not analysed

Hip-waist ratio

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Population: Safety Analysis Set

BMI in kg/m^2

Outcome measures

Measure	VeSTAL - Active Device n=116 Participants 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.	Sham Device n=122 Participants 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.
Body Mass Index (BMI) Baseline	36.9 kg/m^2 Standard Deviation 6.68	35.9 kg/m^2 Standard Deviation 5.78
Body Mass Index (BMI) 6 months	36.6 kg/m^2 Standard Deviation 6.94	34.8 kg/m^2 Standard Deviation 6.25

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 3, Month 6 (or other specified time points)

Population: ITT

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.

Outcome measures

Measure	VeSTAL - Active Device n=117 Participants 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.	Sham Device n=124 Participants 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.
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality Increase in cardiovascular medication	2 Participants	4 Participants
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality Decrease in cardiovascular medication	1 Participants	3 Participants
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality No change in cardiovascular medication	24 Participants	28 Participants
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality N/A	1 Participants	0 Participants
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality Not reported	89 Participants	89 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 3, Month 6 (or other specified time points)

Population: ITT

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.

Outcome measures

Measure	VeSTAL - Active Device n=117 Participants 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.	Sham Device n=124 Participants 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.
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality Medication knwon ro cause weight gain	34 Participants	42 Participants
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality Medication known to cause weight loss	23 Participants	29 Participants
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality Not reported	60 Participants	53 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Percentage Weight Loss from Baseline, by Treatment and Treatment Compliance at 3 months and 6 months

Population: ITT

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%

Outcome measures

Measure	VeSTAL - Active Device n=117 Participants 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.	Sham Device n=124 Participants 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.
Dose Response Analysis Month 6 Low	-1.46 % weight loss Standard Deviation 4.320	-1.00 % weight loss Standard Deviation 4.073
Dose Response Analysis Month 3 High	-2.60 % weight loss Standard Deviation 3.105	-3.51 % weight loss Standard Deviation 3.951
Dose Response Analysis Month 3 Medium	-2.48 % weight loss Standard Deviation 2.825	-1.38 % weight loss Standard Deviation 3.276
Dose Response Analysis Month 3 Low	-1.79 % weight loss Standard Deviation 3.060	-0.84 % weight loss Standard Deviation 2.939
Dose Response Analysis Month 6 High	-4.26 % weight loss Standard Deviation 4.070	-4.73 % weight loss Standard Deviation 5.223
Dose Response Analysis Month 6 Medium	-3.64 % weight loss Standard Deviation 3.490	-1.24 % weight loss Standard Deviation 5.407

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Population: Safety analysis set

Hearing Loss (Judged to be abnormal, normal or missing by examining clinician by audiometry results).

Outcome measures

Measure	VeSTAL - Active Device n=116 Participants 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.	Sham Device n=122 Participants 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.
Hearing Loss Assessment Baseline · Abnormal	7 Participants	3 Participants
Hearing Loss Assessment Baseline · Normal	109 Participants	119 Participants
Hearing Loss Assessment Baseline · Missing	0 Participants	0 Participants
Hearing Loss Assessment Month 6 · Abnormal	6 Participants	3 Participants
Hearing Loss Assessment Month 6 · Normal	73 Participants	77 Participants
Hearing Loss Assessment Month 6 · Missing	37 Participants	42 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: ITT

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.

Outcome measures

Measure	VeSTAL - Active Device n=109 Participants 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.	Sham Device n=114 Participants 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.
Food Frequency Questionnaire Fibre	28.48 grams Standard Deviation 22.071	29.69 grams Standard Deviation 15.287
Food Frequency Questionnaire Alcohol	5.3 grams Standard Deviation 8.302	5.41 grams Standard Deviation 9.922
Food Frequency Questionnaire Carbohydrate	230.95 grams Standard Deviation 128.239	234.69 grams Standard Deviation 171.041
Food Frequency Questionnaire Free sugars	62.97 grams Standard Deviation 53.947	65.86 grams Standard Deviation 80.208
Food Frequency Questionnaire Sugars	122.17 grams Standard Deviation 79.046	130.20 grams Standard Deviation 104.795
Food Frequency Questionnaire Starch	99.92 grams Standard Deviation 61.226	96.03 grams Standard Deviation 67.388
Food Frequency Questionnaire Fat	117.40 grams Standard Deviation 58.807	113.19 grams Standard Deviation 70.277
Food Frequency Questionnaire Saturated Fat	46.55 grams Standard Deviation 26.980	43.76 grams Standard Deviation 32.643
Food Frequency Questionnaire Protein	130.21 grams Standard Deviation 46.945	124.81 grams Standard Deviation 61.433

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3-months and 6-months

Population: ITT

Fat intake as assessed by 24 hour dietary recall.

Outcome measures

Measure	VeSTAL - Active Device n=115 Participants 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.	Sham Device n=122 Participants 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.
Fat Intake Baseline	78.73 Fat (g) Standard Deviation 38.935	78.51 Fat (g) Standard Deviation 37.884
Fat Intake Month 3	66.15 Fat (g) Standard Deviation 25.570	67.08 Fat (g) Standard Deviation 32.377
Fat Intake Month 6	71.89 Fat (g) Standard Deviation 28.724	72.87 Fat (g) Standard Deviation 68.834

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3-months and 6-months

Population: ITT

Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall

Outcome measures

Measure	VeSTAL - Active Device n=115 Participants 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.	Sham Device n=122 Participants 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.
Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars Baseline	191.68 grams Standard Deviation 79.983	188.01 grams Standard Deviation 84.253
Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars Month 3	170.88 grams Standard Deviation 64.303	165.94 grams Standard Deviation 66.797
Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars Month 6	158.55 grams Standard Deviation 69.894	178.29 grams Standard Deviation 159.162

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3-months and 6-months

Population: ITT

Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

Outcome measures

Measure	VeSTAL - Active Device n=115 Participants 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.	Sham Device n=122 Participants 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.
Fiber Baseline	19.31 grams Standard Deviation 7.831	19.54 grams Standard Deviation 8.989
Fiber Month 3	19.79 grams Standard Deviation 7.938	18.61 grams Standard Deviation 9.378
Fiber Month 6	18.25 grams Standard Deviation 6.570	18.62 grams Standard Deviation 9.227

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3-month, and 6-month

Population: ITT

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).

Outcome measures

Measure	VeSTAL - Active Device n=37 Participants 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.	Sham Device n=40 Participants 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.
Alcohol Baseline	23.67 grams Standard Deviation 17.900	26.38 grams Standard Deviation 20.501
Alcohol Month 3	22.45 grams Standard Deviation 17.948	16.63 grams Standard Deviation 11.682
Alcohol Month 6	25.02 grams Standard Deviation 23.928	21.63 grams Standard Deviation 20.519

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Nutrient intakes assessment from two-day 24-hour recall. Score out of 100 with a higher score reflecting a better quality of diet.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Population: ITT

Total Physical Activity averaged over the past year in MET-hours per week as assessed by the Modifiable Activity Questionnaire

Outcome measures

Measure	VeSTAL - Active Device n=114 Participants 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.	Sham Device n=119 Participants 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.
Total Physical Activity in MET-hours Per Week Baseline	57.19 MWET-hours/Week Standard Deviation 83.990	43.17 MWET-hours/Week Standard Deviation 58.502
Total Physical Activity in MET-hours Per Week Month 6	41.19 MWET-hours/Week Standard Deviation 53.354	41.85 MWET-hours/Week Standard Deviation 57.977

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3-months and 6-months

Population: ITT

Saturated fat intake as assessed by 24 hour dietary recall.

Outcome measures

Measure	VeSTAL - Active Device n=115 Participants 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.	Sham Device n=122 Participants 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.
Saturated Fat Intake Month 3	22.33 Saturated Fat (g) Standard Deviation 12.765	22.23 Saturated Fat (g) Standard Deviation 12.678
Saturated Fat Intake Baseline	26.11 Saturated Fat (g) Standard Deviation 14.820	27.16 Saturated Fat (g) Standard Deviation 15.163
Saturated Fat Intake Month 6	24.73 Saturated Fat (g) Standard Deviation 12.761	25.97 Saturated Fat (g) Standard Deviation 28.760

Adverse Events

VeSTAL - Active Device

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Sham Device

Serious events: 0 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	VeSTAL - Active Device n=116 participants at risk 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.	Sham Device n=122 participants at risk 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.
Nervous system disorders Dizziness	20.7% 24/116 • 6 months	30.3% 37/122 • 6 months
General disorders Fatigue	15.5% 18/116 • 6 months	15.6% 19/122 • 6 months
Nervous system disorders Headache	15.5% 18/116 • 6 months	9.8% 12/122 • 6 months
Ear and labyrinth disorders Ear Pain	11.2% 13/116 • 6 months	9.0% 11/122 • 6 months
Ear and labyrinth disorders Mild Tinnitus	15.5% 18/116 • 6 months	3.3% 4/122 • 6 months
Skin and subcutaneous tissue disorders Skin Irritation	10.3% 12/116 • 6 months	7.4% 9/122 • 6 months
Gastrointestinal disorders Nausea	12.1% 14/116 • 6 months	2.5% 3/122 • 6 months

Additional Information

Head of Clinical and Regulatory

Neurovalens

Phone: 02890991835

Email: sinead.watson@neurovalens.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place