Trial Outcomes & Findings for Effect of Vestibular Stimulation on Fat Consumption and Energy Expenditure as Assessed Using Indirect Calorimetry (NCT NCT03138382)

Results Overview

Change in percent fat utilization from baseline as measured using indirect calorimetry.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

During middle 15 minutes of 45 minute vestibular nerve stimulation session

Results posted on

2019-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Then Sham 20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry. Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement. Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.	Sham Then Treatment 20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry. Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement. Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Then Sham n=10 Participants 20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry. Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement. Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.	Sham Then Active n=10 Participants 20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry. Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement. Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.	Total n=20 Participants Total of all reporting groups
Age, Continuous	53 years n=10 Participants	47 years n=10 Participants	50 years n=20 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	6 Participants n=10 Participants	12 Participants n=20 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	4 Participants n=10 Participants	8 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	10 participants n=10 Participants	20 participants n=20 Participants

PRIMARY outcome

Timeframe: During middle 15 minutes of 45 minute vestibular nerve stimulation session

Change in percent fat utilization from baseline as measured using indirect calorimetry.

Outcome measures

Outcome measures
Measure	Sham n=20 Participants 20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry. Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement. Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.	Active n=20 Participants 20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry. Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement. Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.
Change in Fat Consumption (During VeNS)	50.23 % of fat as metabolic substrate Standard Deviation 13.05	54.44 % of fat as metabolic substrate Standard Deviation 14.24

SECONDARY outcome

Timeframe: During middle 15 minutes of 45 minute vestibular nerve stimulation session

Change in energy expenditure from baseline in kcal/min as measured using indirect calorimetry.

Outcome measures

Outcome measures
Measure	Sham n=20 Participants 20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry. Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement. Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.	Active n=20 Participants 20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry. Vestibular Nerve Stimulator: Electrical stimulation of the vestibular nerve for for 45 minutes using binaural mastoid placement. Sham stimulator: Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.
Change in Energy Expenditure (During VeNS)	1.01 kcal/min Standard Deviation 0.26	1.02 kcal/min Standard Deviation 0.24

Adverse Events

Treatment Then Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Then Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Paul McGeoch

UCSD

Phone: 858-232-3312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place