Main objective of the study is to determine the optimal angle of illumination and intensity of blue LEDs fitted to glasses, to induce non-visual responses
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
nvt
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study 1: pupil size changes in response to light exposure. Study 2: melatonin
suppression in response to light
Secondary outcome
visual comfort, alertness and performance in response to light exposure
Background summary
Stimulux® is a new medical product to be designed as a light treatment device.
It consists of glasses fitted with blue LED lights. Main research question of
the study is: Is the angle of illumination important to elicit non-visual
responses and if so, are the effects of different non-visual responses
different for different illumination angles.
Study objective
Main objective of the study is to determine the optimal angle of illumination
and intensity of blue LEDs fitted to glasses, to induce non-visual responses
Study design
Within-subject, randomly assigned crossover study-design.
Intervention
Blue LED light exposure, LEDs fitted to glasses, of varying intensity and
varying angle of illumination. In study 1, subjects will be exposed to pulses
of 30 sec. In study 2, subjects will be exposed to a selection of intensities
and angle of illumination, based on the results in study 1, with a light pulse
duration of 1.5 hours.
Study burden and risks
There are no risks involved from participating in the study. Stimulux is tested
to be safe by two independent, internationally expert safety institutes, there
is no blue light hazard risk. Visual comfort and complaints will be monitored
throughout and subjects will undergo an eye check before and after study 2.
Time investment and burden of the healthy individuals is relatively low. In
study 1, participants have to come to the institute on one morning of afternoon
and the experiment lasts 2 hours. There will be enough breaks to make it
comfortable for the subjects, since they have to sit still to do the
measurements. Study 2 takes a bit more time. Subjects are asked to come to the
institute five times, for 3.5 hours each time, in the evening. this will result
in some sleep deprivation. The measurements, like saliva collection, and simple
ratings and performance tests on the computer will be of very low burden.
Turnhoutseweg 30
Beerse B-2340
BE
Turnhoutseweg 30
Beerse B-2340
BE
Listed location countries
Age
Inclusion criteria
Healthy men and women; ages between 20-35y to avoid the lens changes that occur with aging
Subjects should be fluent in Dutch (because of the use of Dutch rating scales). Signed informed consent.
Exclusion criteria
You suffer from (chronic) disease (physical or psychological)
You suffer from sleep disorders (mild sleep complains are not a problem)
You are visually impaired or you had undergo eye surgery in the last year (contact lenses and glasses are not a problem)
You are taking medication or have taken long-term effects medication in the 3 months prior to participation, which are known to increase the sensitivity to light (see leaflet)
You use regular sleep medication or stimulants
Two or more time zones transmeridian flights one month prior to participation
Shift work during the 3 months prior to participation
Colour blindness
Excessive daily amounts of caffeinated drinks (>8 cups/drinks per day. E.g., coffee, cola, energy drinks)
Alcohol (more than 3 glasses on a working day) or drug problems
The use of melatonin
Design
Recruitment
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 | NL45834.042.13 |