Vestibular Nerve Stimulation to Improve Sleep

Not Applicable

Completed

• Conditions: Insomnia; Sleep Disorders, Circadian Rhythm; Sleep
• Interventions: Device: Placebo device; Device: VeNS

• Registration Number: NCT04219566
• Lead Sponsor: Neurovalens Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Study Start: 2020-03-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham VeNS	Placebo device	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.
Active VeNS	VeNS	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.

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index (ISI) Scores	Day 0, Day 7, Day 14, Day 21, Day 28	ISI scores will be measured during the study and will be compared to baseline readings taken prior to intervention. Insomnia Severity Index scores range from 0 to 28. Scores greater than 15 indicate clinical insomnia.

Secondary Outcome Measures

Name	Time	Method
WHO Quality of Life (WHOQOL) Assessment	Day 0, Day 7, Day 14, Day 21, Day 28	QOL will be measured during the study and will be compared to baseline readings taken prior to intervention. WHOQOL is scored from 0 to 100 with higher scores indicating a higher quality of life.
EEG Assessment	Day 0, Day 28	EEG power in alpha band
Depression Anxiety Stress Scales (DASS) Assessment	Day 0, Day 7, Day 14, Day 21, Day 28	DASS will be measured during the study and will be compared to baseline readings taken prior to intervention. DASS is scored from 0 to 42 with higher scores indicating more symptoms.

Trial Locations

Locations (1)

RD Gardi Medical College; 🇮🇳 Ujjain, Madhya Pradesh, India