NCT00594022

Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This 2 arm study will look at the proposed treatment (electrical stimulation of the vestibular nerve) versus a sham or placebo device. The effect of the device will be evaluated in a study that uses normal sleepers and advances them(puts them to bed 5-hours earlier than normal) to see if they fall asleep faster in one group or the other. Stimulation in the treated or sham group is only for the first hour after lights off.

Conditions

• Insomnia
• Sleeplessness
• Transient Insomnia

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-06-01
• Completion: 2008-07-01
• First posted: 2008-01-15
• Last updated: 2019-01-07
• Results posted: 2016-08-23

Locations

6 sites across 1 country: United States