349
Participants
Start Date
October 31, 2007
Primary Completion Date
June 30, 2008
Study Completion Date
July 31, 2008
"Electric stimulation of the Vestibular Nerve - VirtuSom"
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 - SHAM"
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.
Clinilabs, New York
University of Rochester, Rochester
Duke University Medical Center, Durham
Neuro Trials, Atlanta
Sleep Disorders Center of Georgia, Atlanta
Tri-State Sleep Disorders Center, Cincinnati
Lead Sponsor
Philips Respironics
INDUSTRY