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 Details — Status: Completed

Administrative data

• NCT number: NCT04219566
• Other study ID #: IVS001S
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: Neurovalens Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Device:
• VeNS
Non-invasive electrical vestibular nerve stimulation
• Placebo device
Sham non-invasive electrical vestibular nerve stimulation

Locations

Country	Name	City	State
India	RD Gardi Medical College	Ujjain	Madhya Pradesh

Sponsors (3)

Lead Sponsor	Collaborator
Neurovalens Ltd.	Compliance Solutions Ltd., RD Gardi Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index (ISI) Scores	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.	Day 0, Day 7, Day 14, Day 21, Day 28
Secondary	EEG Assessment	EEG power in alpha band	Day 0, Day 28
Secondary	Depression Anxiety Stress Scales (DASS) Assessment	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.	Day 0, Day 7, Day 14, Day 21, Day 28
Secondary	WHO Quality of Life (WHOQOL) Assessment	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.	Day 0, Day 7, Day 14, Day 21, Day 28