Pilot study to investigate the effects of photobiomodulation on health and wellbeing of people with chronic sleep deprivatio
- Conditions
- Mood, sleepiness, subjective/objective performance, need for recovery, cortisol. Sleep timing and quality, melatonin rhythms, heart rate variability, immune response, vitamin D and skin temperaturewell-being sleep
- Registration Number
- NL-OMON55059
- Lead Sponsor
- Seaborough Life Science B.V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
* Healthy, no chronic disease
* Age between 25 * 65 years
* Average sleep duration during a week <<= 6.5 hours and/or an accumulated sleep
deficit of at least 2 hours (sum of the accumulated difference in sleep
duration of working days with weighted average sleep duration per week) *
measured with MCTQ
* Suffer from daytime sleepiness (ESS>5 or BDI equal to or higher than 13 but
lower than 20
* Dutch speaking
* Participants will have to have a desk type of work and/or have 3 hours per
day between 9:30 am and 12:30 at their office/home in which they could sit in
front of the lamp.
1. Depressive mood (BDI -II > 19)
2. Pregnancy
3. Drug use during the last three months known to interfere with sleep,
alertness, the biological clock and/or light sensitivity (i.e. regular usage of
sleep medication or stimulating substances)
4. Use of immune suppressants.
5. High levels of caffeine intake during a day (5 or more cups)
6. High alcohol intake (more than 4 for men and more than 3 for women) for more
than 5 days in the past month
7. Participant is not able to refrain from using recreational drugs during the
4 weeks of the study.
8. Shift work schedule in the 3 months prior to participation and/or planned
during the 4 weeks of the study
9. Environmental factors in everyday life that may disturb sleep and cannot be
prohibited (e.g. young children, noisy environment)
10. Travel over 2 or more time zones in the month prior to participation
11. Travel to sunny holiday locations/wintersports 1 month before participation
12. Personal plans that prevent them for using the intervention during 4
consecutive weeks
13. Menopausal transition complaints
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>subjective mood, subjective and objective performance, need for recovery,<br /><br>sleepiness, subjective and objective sleep quality, sleep timing, immune<br /><br>outputs, cortisol level, melatonin phase and total overnight amounts, heart<br /><br>rate variability</p><br>
- Secondary Outcome Measures
Name Time Method <p>skin temperature and vitamin D, possible interaction with season</p><br>