Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

Not Applicable

Completed

Conditions: Sleeplessness
Insomnia
Transient Insomnia

Interventions: Device: Electric stimulation of the Vestibular Nerve - "VirtuSom"
Device: Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM

Registration Number: NCT00594022

Lead Sponsor: Philips Respironics

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 349

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1- "VirtuSom" - Stim	Electric stimulation of the Vestibular Nerve - "VirtuSom"	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).
Group 2- "VirtuSom"- Sham	Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM	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).

Primary Outcome Measures

Name	Time	Method
Latency to Persistent Sleep (LPS)	Treatment Night	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.

Secondary Outcome Measures

Name	Time	Method
Scored Sleep Onset Latency (SOL on PSG)	Treatment Night	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.
Total Sleep Time (TST) in the First Hour After Lights Out	Treatment night	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.
Subjective Sleep Onset Latency (SOL)	Treatment night	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.
Total Sleep Time (TST) in the First 2 Hours After Lights Out	Treatment night	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.

Trial Locations

Locations (6): Clinilabs
🇺🇸
New York, New York, United States
Sleep Disorders Center of Georgia
🇺🇸
Atlanta, Georgia, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Neuro Trials
🇺🇸
Atlanta, Georgia, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Tri-State Sleep Disorders Center
🇺🇸
Cincinnati, Ohio, United States