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Vestibular Nerve Stimulation to Improve Sleep

Insomnia Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04219566
Study type Interventional
Source Neurovalens Ltd.
Contact
Status Completed
Phase N/A
Start date March 1, 2020
Completion date July 31, 2022
View Details
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