Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MR-0513-VSOM-MS
Study information
Scientific title
Double-Blind, Placebo-Controlled, Parallel Group Study of VSOM-4.16 for Circadian Phase Advancement
Acronym
Study hypothesis
Use of VSOM-4.16 will decrease the time necessary for experimentally phase-advanced normal sleepers to fall asleep compared with placebo
Ethics approval
Ethics approval not yet received as of 11/04/2006
Study design
Randomized double blind
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Circadian phase advance
Intervention
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 phase of their sleep schedule to fall asleep faster.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Latency to persistent sleep onset
Secondary outcome measures
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
Overall trial start date
20/02/2006
Overall trial end date
20/08/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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 <8 minutes across five naps, or one sleep onset rapid eye movement [REM] period on any MSLT nap
11. Sleep efficiency >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)
Recruitment start date
20/02/2006
Recruitment end date
20/08/2006
Locations
Countries of recruitment
United States of America
Trial participating centre
Box 3309
North Carolina
27710
United States of America
Funders
Funder type
University/education
Funder name
Duke University Medical Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Harvard Medical School
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United States of America
Funder name
Clinilabs Inc.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Rush University Medical Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Arizona College of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Respironics Inc.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary