Circadian phase advance Nervous System Diseases Circadian phase advance
Conditions
Interventions
VSOM-4.16 versus placebo. VSOM-4.16 is a device that electrically stimulates peripheral sensory receptors which appears to have an indirect effect of allowing individuals undergoing an advance in the
Sponsors
Duke University Medical Center (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females, ages 21-60 (inclusive) 2. Able and willing to provide written informed consent 3. Reported habitual bedtime between 2100 and 0100 hours, which does not vary by more than one hour at least five nights per week (for example if the habitual bedtime is 12:00 then the time to bed should be between 11:30 and 12:30) 4. Reported habitual nightly sleep duration of 6.5 to 8.5 hours 5. Habitual bedtime and sleep duration consistent with reported habitual bedtime and sleep duration as determined by sleep log and 7 to 14 days of actigraphic monitoring
Exclusion criteria
Exclusion criteria: 1. Participation in a study of investigational or marketed drugs or devices during the 30-day period before the start of the study or during the study 2. Clinically significant medical or psychiatric condition 3. Probable diagnosis of a current sleep disorder including but not limited to insomnia, sleep apnea, restless legs syndrome, or periodic limb movement disorder 4. Positive urine drug screen at any visit prior to randomization 5. Positive alcohol saliva test at any visit prior to randomization 6. History of current or recent (e.g. within past five years) alcohol, narcotic or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition (DSM-IV) 7. Currently works night shift or rotating shift 8. Travel or planned travel across more than two time zones within one week prior to randomization 9. Use of any medication that, in the opinion of the investigator, may alter sleep or wakefulness 10. Mean screening (multiple sleep latency test [MSLT] of 94% per screening polysomnography (PSG) 12. An apnea/hypopnea index >10 per hour, or a periodic limb movement with arousal index >10 per hour on the screening PSG 13. Consumption of more than 14 alcoholic drinks per week, or the recent consumption of more than four alcoholic drinks in one night 14. Typically consumes more than five caffeinated beverages per day 15. Regular use of tobacco products (i.e. more than one pack of cigarettes per day) 16. Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing age) 17. Presence of a pacemaker 18. Presence of epilepsy or other uncontrolled medical conditions 19. Prior participation in a VSOM protocol 20. History of vestibular disorders (such as vertigo)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Latency to persistent sleep onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Polysomnographic measures: 1. Total sleep time 2. Sleep efficiency 3. Number of awakenings 4. Wake after sleep onset 5. Minutes in each sleep stage (1, 2, 3-4 non-rapid eye movement [NREM] and REM) 6. Minutes of slow wave sleep during each quartile of the night Subjective measures: 1. Ratings of sleep latency 2. Total sleep time 3. Sleep quality 4. Number of awakenings 5. Quality of sleep 6. Level of alertness in the morning | — |
Countries
United States of America
Outcome results
None listed