Pilot study to investigate the effects of photobiomodulation on health and wellbeing of people with chronic sleep deprivation

In Western societies, people spend ~87% of their waking hours indoors. This
leads, between many other things, to light deprivation. While outdoor lighting
can easily reach a hundred thousand lux in intensity with a broad spectrum,
going from the very (near) infrared (NIR) up to UV light, indoor light
intensities barely reach the 500 lux and it often represents only some small
wavelengths peaks within the visible range. NIR exposure (760*940 nm) is
completely lacking. Light is not only needed for vision but it can also assert
a broader spectrum of responses such as affecting sleep-wake rhythms, sleep
quality, alertness, mood, and performance. Focus for these effects has recently
been on the short-wavelengths, while near infrared light (NIR) has sometimes
been used to treat a broad range of medical aspects such as wound healing,
inflammation, and pain. This last topic, exposure to near infrared light, is
known as photobiomodulation (PBM). One of the mechanisms underlying the health
effects of NIR is thought to be by stimulating mitochondria. Mitochondrial
dysfunction has been discussed to underly several health complaints and one of
the reasons why people may suffer from mitochondrial dysfunction has been
suggested to be a chronic sleep deficit and/or circadian misalignment. The
hypothesis tested in the current explorative study is that PBM will improve
health and well-being in subjects suffering from sleep deficits.

Main objective of the current study is to explore in a dose response manner the
potential short and long term effects of PBM on several aspects related to
health and well-being

The study is a double-blind placebo-controlled dose response study with two
phases. In phase 1, short term (acute and days) effects will be measured. In
phase 2, long term (weeks) effects will be investigated. Three different doses
and a placebo condition of PBM will be tested and subjects will be randomized
by stratification so that each subject is assigned to 1 of the 4 conditions

The four different doses are: 0 J (placebo), low, medium and high. The PBM
dose will be established by changing the duration of the PBM, synchronized at
turning off at 1:30 p.m. and/or the pulse frequency. Dose and timing will be
programmed into the device, so that no user intervention will be necessary.

During 20 days, participants must use the PBM device at home or at the office,
for 3 hours between 9:30 am and 12:30 pm. This is not really a burden, as the
device is a normal desk lamp. The only limitation is that they have to sit at
their desk for those 3 hours. Subjects have to take extensive tests twice
during the first two days of using the PBM, this will take about 4 hours each
time. In addition, subjects will collect data at home for a total of 5 nights:
one baseline night, two consecutive nights after the first two PBM sessions,
and 2 nights after 2 and 4 weeks, respectively. During these nights they
complete questionnaires, collect saliva and urine at night. A blood sample and
a hair sample (not after 2 weeks) are taken at baseline, at 2 weeks, and at 4
weeks. During the total period of 4 weeks, subjects wear a resting activity
monitor on the wrist and a Fitbit Versa 3; they also wear a heart rate monitor
for the first two days. All devices are used for ambulatory admissions and do
not hinder the person's movement. There are no risks associated with
participation. When PBM works, subjects can benefit from better sleep, better
mood, performance, etc.