Main objective of the study is to shift rhythms in late chronotypes and thereby lengthen sleep on workdays and align endogenous rhythms
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
circadian alignment
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the timing and quality of the sleep wake cycle
Secondary outcome
Secondary study parameters are the rhythm of melatonin, performance and
sleepiness during wakefulness, adverse events and movements during sleep
Background summary
Sleeping out of phase with the external light-dark cycle, especially late
sleep, is a phenomenon in our society that often results in sleep deficits and
a mismatch between endogenous and external rhythms, leading to difficulty in
waking up and being alert at work, and to health problems. An estimate of the
number of people suffering from an extreme late phase (more than 3 hours out of
phase with regular sleeping hours) amounts to 4% in the Netherlands. There are
indications that even living 1 hour out of phase has detrimental health effects
in vulnerable people, and it has been demonstrated that modifying the start
time of school in adolescents by only 30 minutes improves alertness, mood and
health. A recent analysis of the Dutch MCTQ database shows that 18% of the
people older than 18 years sleep more than 1h later than the average of the
database population. This means that a large number of people in the population
could theoretically benefit from a correction of their timing of sleep.
Study objective
Main objective of the study is to shift rhythms in late chronotypes and thereby
lengthen sleep on workdays and align endogenous rhythms
Study design
In a matched placebo controlled trial we will test whether several days of
advancing blue light exposure is capable of inducing a phase shift of the sleep
wake cycle.
Intervention
Blue light exposure with sleep hygiene instructions
Study burden and risks
There are no clear risks of participating in this study. The device is tested
for ocular safety and has been proven to be safe. Burden of the subjects is
mainly an investment of time. Subjects participate in one condition each, that
lasts 30 days. They have to wear two devices continuously, they have to collect
saliva at regular intervals, and perform some tests. All measurement will be
carried out at home. The volunteers may benefit from the treatment with an
improvement of sleep, a reduction of daytime sleepiness and better performance.
P.O. Box 20100
9200 CA Drachten
NL
P.O. Box 20100
9200 CA Drachten
NL
Listed location countries
Age
Inclusion criteria
• Healthy men and women ages between 18 and 65 years
• Social jetlag (difference between midsleep on workdays and days off), of at least 1 hour.
• Sleep duration is shorter on workdays than on days off
• If subjects are allowed to sleep at the time they choose, they have no sleep complaints
• Subjects are motivated to phase advance their sleep times.
• Subjects should be fluent in Dutch (because of the use of Dutch rating scales).
Exclusion criteria
Other sleep disorders, eg sleep apnoea, narcolepsy, restless legs, primary insomnia; depressive disorder; shiftwork during the period 3 months prior to participation or transmeridian flights during one month prior to participation; colour blindness or visually impaired; serious eye problems, e.g. glaucoma; chronic use of medication; excessive daily amounts of caffeinated drinks, alcohol or drugs; the use of photosensitizing medication
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36018.042.11 |