NCT04452981

Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia

A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control For Treatment Of Insomnia.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the treatment of insomnia 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 insomnia, 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. 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 insomnia.

Conditions

• Insomnia
• Sleep Disturbance

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 1 hour per day.

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-01-03
• Completion: 2023-01-03
• First posted: 2020-07-01
• Last updated: 2024-01-16

Locations

2 sites across 2 countries: Hong Kong, United Kingdom