Vestibular Nerve Stimulation to Improve Sleep

Neurovalens

Status: Completed

Conditions: Insomnia; Sleep Disorders, Circadian Rhythm; Sleep

Treatments: Device: Placebo device; Device: VeNS

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04219566

IVS001S

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Active VeNS

Active Comparator group

Description:

The VeSTAL 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 in the period immediately prior to sleep onset.

Treatment:

Device: VeNS

Sham VeNS

Sham Comparator group

Description:

The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. 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 in the period immediately prior to sleep onset.

Treatment:

Device: Placebo device