Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

Completed · Not applicable · Has a placebo group

Conditions studied: Insomnia, Sleeplessness, Transient Insomnia

In brief

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.

Key facts

Study ID

NCT00594022

Run by

Philips Respironics

People needed

349

Starts

2007-10-01

Expected to finish

2008-07-01

Last updated by the study team

2019-01-07

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• 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
• Duke University Medical Center — Durham, North Carolina, United States
• Tri-State Sleep Disorders Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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