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

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).

Inclusion Criteria:

• Adults
• Both genders
• Ages 18-24 years inclusive
• Score above 14 in the insomnia severity index questionnaire
• Willingness to participate in the study.

Exclusion Criteria:

• Use sleep medication
• Ear problems
• Under any kind of treatment
• Practicing sleep improving techniques
• Any other significant health-related problems.