Condition category
Nervous System Diseases
Date applied
09/02/2006
Date assigned
11/04/2006
Last edited
09/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Krystal

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Duke University Medical Center (USA)

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes