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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
349
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.
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.
Neuro Trials
Atlanta, Georgia, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States
Clinilabs
New York, New York, United States
University of Rochester
Rochester, New York, United States
Latency to Persistent Sleep (LPS)
Latency to Persistent Sleep is how long does it take for a person to fall asleep and stay asleep. This is measured in minutes. This is different from sleep onset latency as participants fall asleep, but may wake back up.
Time frame: Treatment Night
Subjective Sleep Onset Latency (SOL)
Subjective sleep onset latency is how long it took a person to fall asleep once lights out. For subjective SOL this is a question to a participant the next morning asking how long they felt it took them to fall asleep in minutes.
Time frame: Treatment night
Total Sleep Time (TST) in the First 2 Hours After Lights Out
Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is for the 2 hours after lights out.
Time frame: Treatment night
Total Sleep Time (TST) in the First Hour After Lights Out
Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is the total amount of sleep a participant gets over the first hour of sleep after lights out.
Time frame: Treatment night
Scored Sleep Onset Latency (SOL on PSG)
Sleep onset latency is the amount of time it takes to fall asleep after the lights have been turned off. For this outcome measure it is as measured by the scored PSG.
Time frame: Treatment Night
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Duke University Medical Center
Durham, North Carolina, United States
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States