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| Name | Class |
|---|---|
| R D Gardi Medical College, Ujjain | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active VeNS | Active Comparator | The active device utilizes a technology 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. |
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| Sham VeNS | Sham Comparator | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. 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 30 minutes per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active VeNS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | To evaluate the safety of the VeNS device relative to control group, in terms of the occurrence of adverse events. | Up to 6 weeks |
| Quality of life using SF-36 scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sai Sailesh Kumar Goothy | R.D. Gardi Medical College, Ujjain, Madhya Pradesh. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry of R.D. Gardi Medical College | Ujjain | Madhya Pradesh | 456001 | India |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
| Sham VeNS | Device | 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. |
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| 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. | Up to 6 weeks |