February, 2012. Helsinki, Finland Valkee, the inventor of the bright light headset, and scientists from the University of Oulu published the first results of the clinical and neurobiological research program conducted since 2007, on human brains light sensitiveness. The clinical trial, published in Medical Hypothesis, studied therapeutic effects of bright light channeled into the human brain via the ear canal.
There is no conclusive evidence that light therapy is only transmitted through the eyes. On the contrary, in mammals, a significant amount of light penetrates the skull and reaches the brain. The brain has photoreceptive proteins such as encephalopsin, and physiological influences have been measured by extra ocular light exposure. Therefore, we challenged the existing paradigm by showing that the brain-targeted bright light therapy via the ear canal is an effective mechanism to relieve seasonal depression, comments Juuso Nissil, Valkees co-founder and chief scientist.
In the published trial, patients received 8-12 minutes of 6.0-8.5 lumen bright light daily into both ear canals for four weeks with a medical Class II(a) device manufactured by Valkee Ltd, called bright light headset. The daily administration time was personalised at the study clinic
The results are strong and promising. 92 % of the patients with severe seasonal affective disorder achieved full remission measured by the self-rated BDI-21 questionnaire. With the psychiatrist-rated HAMD-17 questionnaire, 77 % of the patients achieved full remission, comments Professor Markku Timonen, MD, PhD, and the lead investigator for the published trial at the University of Oulu. The full remission criteria was BDI-21 and HAMD-17 sum score ≤ 7
Valkee introduced its bright-light headset in August 2010 and has today broad user base. Being based on cross-functional science in neurology, biology, psychiatry and physiology in University of Oulu, Finland, Valkee is a CE-certified Class II (a) medical device under the EU regulations