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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Non-invasive electrical vestibular nerve stimulation
Sham non-invasive electrical vestibular nerve stimulation
RD Gardi Medical College
Ujjain, Madhya Pradesh, India
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.
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28
EEG Assessment
EEG power in alpha band
Time frame: Day 0, Day 28
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.
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28
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.
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28
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