CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 349 enrolled
Drug / intervention
Electric stimulation of the Vestibular Nerve - "VirtuSom" +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00594022
NCT00594022N/ACompleted
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The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time

Philips Respironics·interventional·Posted Jan 15, 2008·Updated Jan 7, 2019

In Brief

A clinical study evaluating Electric stimulation of the Vestibular Nerve - "VirtuSom" and Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM for Insomnia and 2 related conditions. Completed, enrolled 349 participants across 6 sites.

Detailed Summary

The purpose of this study is to determine whether a small electrical current to the vestibular nerve (balance organ) will decrease the time it take for participants to fall asleep.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Sleeplessness, Transient Insomnia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2008
Enrollment StartOct 1, 2007
Primary CompletionJun 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.5 years ago

Interventions

Electric stimulation of the Vestibular Nerve - "VirtuSom"device

This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes.

Electric stim of the Vestibular Nerve - "VirtuSom" - SHAMdevice

This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only.