NCT05907967

Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety

A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Anxiety is known to be one of the most common health concerns in in the general population, and the most common mental health issue, and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for anxiety but comes with a risk of adverse effects. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of anxiety but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and anxiety continues to be explored, however its usefulness in the treatment of anxiety is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the treatment of anxiety, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. It also could present an alternative intervention for patients who are non-responsive or refuse medication. Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with anxiety.

Conditions

• Anxiety

Interventions

Type	Name	Description
DEVICE	VeNS	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.

Timeline

• Start date: 2022-07-18
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2023-06-18
• Last updated: 2024-01-16

Locations

1 site across 1 country: United Kingdom