Double-Blind, Placebo-Controlled, Parallel Group Study of VSOM-4.16 for Circadian Phase Advancement

ISRCTN	ISRCTN07336279
DOI	https://doi.org/10.1186/ISRCTN07336279
Secondary identifying numbers	MR-0513-VSOM-MS

Submission date: 09/02/2006
Registration date: 11/04/2006
Last edited: 09/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Krystal
Scientific

Box 3309
Duke University Medical Center
Durham
North Carolina
27710
United States of America

Study information

Study design	Randomized double blind
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Double-Blind, Placebo-Controlled, Parallel Group Study of VSOM-4.16 for Circadian Phase Advancement
Study objectives	Use of VSOM-4.16 will decrease the time necessary for experimentally phase-advanced normal sleepers to fall asleep compared with placebo
Ethics approval(s)	Ethics approval not yet received as of 11/04/2006
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/02/2006
Completion date	20/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Key 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
Key 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)
Date of first enrolment	20/02/2006
Date of final enrolment	20/08/2006

Locations

Countries of recruitment

United States of America

Study participating centre

Box 3309

North Carolina
27710
United States of America

Sponsor information

Duke University Medical Center (USA)
University/education

Box 3309
Duke University Medical Center
Durham
North Carolina
27710
United States of America

"ROR"	https://ror.org/03njmea73

Funders

Funder type

University/education

Duke University Medical Center

No information available

Harvard Medical School
Private sector organisation / Universities (academic only)

Alternative name(s): Harvard Med School, HMS
Location: United States of America

Clinilabs Inc.

No information available

Rush University Medical Center

No information available

University of Arizona College of Medicine

No information available

Respironics Inc.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan