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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04219566

Enrollment

Registered

2020-01-07

Start date

2020-03-01

Completion date

2022-07-31

Last updated

2022-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Sleep, Sleep Disorders, Circadian Rhythm

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).

Interventions

DEVICEVeNS

Non-invasive electrical vestibular nerve stimulation

DEVICEPlacebo device

Sham non-invasive electrical vestibular nerve stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double Blind (Subject, Nursing staff, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 24 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026