|
ISRCTN
|
ISRCTN07336279
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Double-Blind, Placebo-Controlled, Parallel Group Study of VSOM-4.16 for Circadian Phase Advancement
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
MR-0513-VSOM-MS
|
|
Study hypothesis
|
Use of VSOM-4.16 will decrease the time necessary for experimentally phase-advanced normal sleepers to fall asleep compared with placebo
|
|
Lay summary
|
|
|
Ethics approval
|
Ethics approval not yet received as of 11/04/2006
|
|
Study design
|
Randomized double blind
|
|
Countries of recruitment
|
United States of America
|
|
Disease/condition/study domain
|
Circadian phase advance
|
|
Participants - 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
|
|
Participants - 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)
|
|
Anticipated start date
|
20/02/2006
|
|
Anticipated end date
|
20/08/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
200
|
|
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 phase of their sleep schedule to fall asleep faster.
|
|
Primary outcome measure(s)
|
Latency to persistent sleep onset
|
|
Secondary outcome measure(s)
|
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
|
|
Sources of funding
|
1. Duke University Medical Center
2. Harvard Medical School
3. Clinilabs Inc.
4. Rush University Medical Center
5. University of Arizona College of Medicine
6. Respironics Inc.
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Andrew
Krystal
|
|
Address
|
Box 3309
Duke University Medical Center
Durham
|
|
City/town
|
North Carolina
|
|
Zip/Postcode
|
27710
|
|
Country
|
United States of America
|
|
Sponsor
|
Duke University Medical Center (USA)
|
|
Address
|
Box 3309
Duke University Medical Center
Durham
|
|
City/town
|
North Carolina
|
|
Zip/Postcode
|
27710
|
|
Country
|
United States of America
|
|
Date applied
|
09/02/2006
|
|
Last edited
|
11/04/2006
|
|
Date ISRCTN assigned
|
11/04/2006
|
