The present study will be conducted at the Department of Physiology in collaboration with the Department of Psychiatry of R.D. Gardi Medical College, Ujjain, Madhya Pradesh. This double-blind randomized controlled trial will remotely enroll 60 subjects. Each participant will complete 20 stimulation sessions at a rate of 3-5 sessions per week. Each session will be 30 minutes on the day of usage. The study will be randomized with a 1:1 active; or sham control allocation. Endpoint analysis will be performed upon completion of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The VeNS 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 30 minutes per day.
The VeNS 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 30 minutes per day.
Department of Psychiatry of R.D. Gardi Medical College
Ujjain, Madhya Pradesh, India
Generalised Anxiety Disorder (GAD-7) Scores
To evaluate the ability of the Modius Stress device, relative to the control group, in the management of anxiety.
Time frame: Up to 6 weeks
Number of adverse events
To evaluate the safety of the VeNS device relative to control group, in terms of the occurrence of adverse events.
Time frame: Up to 6 weeks
Quality of life using SF-36 scores
Time frame: Up to 6 weeks
Insomnia Severity Index (ISI) score
To evaluate the effect of the VeNS device, relative to control group on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia.
Time frame: Up to 6 weeks
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