NCT04219566

Vestibular Nerve Stimulation to Improve Sleep

Pilot Study to Demonstration of Safety and Efficacy of VeSTAL Sleep Device in Human Subjects: Randomized Study of VeSTAL Compared to Sham Control as a Means of Improving Sleep as Determined by ISI Scores

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

Summary

A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings The purpose of this investigation device study is to collect data that will be used to design appropriate pivotal studies that can be used for regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).

Conditions

• Insomnia
• Sleep
• Sleep Disorders, Circadian Rhythm

Interventions

Type	Name	Description
DEVICE	VeNS	Non-invasive electrical vestibular nerve stimulation
DEVICE	Placebo device	Sham non-invasive electrical vestibular nerve stimulation

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2020-01-07
• Last updated: 2022-10-21

Locations

1 site across 1 country: India