Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insomnia, Sleeplessness, Transient Insomnia

Intervention / Treatment
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* Device: Electric stimulation of the Vestibular Nerve - VirtuSom
* Device: Electric stim of the Vestibular Nerve - VirtuSom - SHAM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, ages 21- 50 attempts will be made to enroll equal distributions of males and females Able and willing to provide written informed consent Self reported habitual bedtime between 2100 and 0100 hours, which does not vary by more than 1 hour at least 5 nights per week Self reported 7.5-9 hrs. habitual sleep time Able to commit to 9 hrs of sleep opportunity throughout the study, but especially for the 3 nights prior to their PSG Pass Berlin questionnaire, i.e. low likelihood of sleep disordered breathing No history or evidence of RLS(restless leg syndrome) /PLMS (periodic limb movement syndrome) /Narcolepsy, no non-respiratory related sleep disorders. Exclusion Criteria: Regular use of a pack or more per day of tobacco products Typically consumes more than 2 (12 oz) caffeinated beverages per day Self reported history of motion sickness Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study Clinically significant medical or psychiatric condition as determined by the investigator Probable diagnosis of a current sleep disorder including but not limited to insomnia, sleep apnea, restless legs syndrome, or periodic limb movement disorder History of current or recent (e.g. within past 5 years) alcohol, narcotic or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV) Currently works night shift or rotating shift Travel or planned travel across more than 1 time zone within one week prior to randomization Use of any medication that, in the opinion of the investigator, may alter sleep or wakefulness. (See Appendix E: Guideline For Medications Commonly Associated With Alterations Of Sleep / Wake Functioning). Subjects will undergo urine drug testing. Consumption of more than 14 alcoholic drinks per week, or the recent consumption of more than 4 alcoholic drinks in one night. Subjects will be tested for alcohol, using a saliva test kit. Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women's of child bearing age). Presence of a pacemaker Presence of epilepsy or other uncontrolled medical conditions. Prior participation in a VirtuSom protocol History of vestibular disorders, (such as vertigo)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1- VirtuSom - Stim<br>Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve). | Device: Electric stimulation of the Vestibular Nerve - VirtuSom<br>* 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.<br>|
| Placebo Comparator: Group 2- VirtuSom- Sham<br>Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve). | Device: Electric stim of the Vestibular Nerve - VirtuSom - SHAM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Treatment Night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Treatment Night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electric Stimulation, Latency to Persistent Sleep (LPS), Transient Insomnia, Insomnia