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Sham-Controlled Bright Light Study Shows Efficacy in Alleviating Anxiety Symptoms

November 21, 2013

OULU, Finland and MONACO (IFMAD Forum), November 21, 2013 /PRNewswire/ –

Results of a New Randomized, Sham-Controlled, Double-Blind Bright Light

Trial Presented at the 13th International Forum on Mood and Anxiety Disorders

The bright light headset maker Valkee today announced the results of a new
groundbreaking bright light study, showing statistically significant positive results in
acutely alleviating anxiety symptoms. The world’s first randomized, fully sham-controlled
double blind trial of bright light treatment administered via ear canals brings
sought-after new data to support the bright light studies carried out internationally
since the 1980s.

Presented at the International Forum on Mood and Anxiety Disorders in Monte Carlo, the
landmark results show a statistically significant acute reduction of anxiety symptoms in
the bright light exposure group. In contrast, the symptoms in the control group receiving
sham treatment did not show significant change. The double-blind trial was carried out
under laboratory conditions using covered versions of Valkee bright light headsets,
ensuring that neither participants nor research personnel were aware of which group a
particular participant belonged to.

While the general perception of bright light treatment has been focused on Seasonal
Affective Disorder (SAD), researchers have long been interested in wider scale benefits.
Typical SAD symptoms such as tiredness and reduced cognitive performance are very similar
to both general anxiety and to other specific anxiety-related disorders. The similarity is
reflected in the US Diagnostic and Statistical Manual of Mental Disorders, which
classifies SAD as a specific type of depression
[http://en.wikipedia.org/wiki/Seasonal_affective_disorder ] instead of an independent
disorder.

About the study

The new research results confirm earlier findings about the benefits of bright light
in treating anxiety with a called-for randomized and controlled trial. A previous key
milestone in this area was an open trial with a large sample of 79 participants reported
by Youngstedt et al. [http://www.biomedcentral.com/imedia/1754395645145232_manuscript.pdf
] in 2007. The study showed significant anxiety relieving effects following acute bright
light exposure in adults with low anxiety levels.

The new double-blind study included 28 participants with moderate anxiety symptoms,
randomly assigned into two groups. Half of the participants received a 12-minute daily
dose of transcranial bright light using blinded Valkee bright light headsets, while the
other half received the same duration of blinded sham exposure. The study was conducted
during the spring and summer months.

“Studying the effects of bright light on anxiety symptoms in more general terms than
only related to seasonal affective disorder makes perfect sense,” said Timo Takala, MD,
Ph.D. and scientific advisor for Valkee. “Based on the new study, bright light acutely
alleviates anxiety symptoms during the light period of the year and not only in relation
to the dark period.”

“The invention of bright light headsets marks a leap forward in bright light research,
as it is now finally possible to organize a sham-controlled double blind research
setting,” said Heidi Jurvelin, Research Manager at Valkee who oversaw collaboration on the
study with Oulu University. “With traditional desktop bright light devices, proper sham
treatment is understandably impossible. Now we used identically blinded Valkee headsets
for both actual and sham treatment, the only difference being inactivated light source for
the sham group.”

The anxiety level of participants was first measured using the Beck Anxiety Inventory
(BAI) score. The mean score of 19 plus or minus 9 signals moderate anxiety symptoms.
During the study, the anxiety symptoms were measured using the Spielberger State-Trait
Anxiety Inventory (STAI, form Y1) self-rating questionnaire, 5 minutes before and 10
minutes after each exposure of bright light or sham treatment. The bright light group
score decreased by 12.1 plus or minus 7.3 %, while the sham group score decreased
non-significantly by 3.7 plus or minus 11.3 %. The difference between the groups is
statistically significant.

The newly presented results will next be submitted for a peer-reviewed publication.
The results also provide a solid “proof of concept” and warrant further anxiety-focused
studies with large number of participants. The long-term scientific research and
placebo-controlled studies carried out by the Valkee science team and researches in the
University of Oulu in Finland and elsewhere build on an array of bright light studies
published since the 1980s. [http://archpsyc.jamanetwork.com/article.aspx?articleid=493246
] The results have confirmed that bright light projected into the ear canal stimulates
brain activity [http://valkee.com/about/science ], and proved the efficiency of the ear
canal as a channel for transmitting light to photosensitive areas of the human brain.

Valkee Bright Light Headset [http://valkee.com/en/#product ] is the world’s first
pocket-sized device that channels bright light via the ear canals into the brain. The
device has a CE Class II(a) medical device certification for treating seasonal affective
disorder (SAD) and is continuously clinically tested.

Link to the conference poster-material:

http://valkee.com/wp-content/uploads/2013/11/Valkee_tiedeposteri2_900x1200_print.pdf

About Valkee:

Valkee is a health technology company focused on harnessing the benefits of bright
light to the human mind and performance. Based on long-term scientific research and
development work together with Finland’s Oulu University, Valkee introduced the world’s
first bright light headset in 2010. Clinically tested to significantly relieve seasonal
affective disorder symptoms in nine out of ten study participants
[http://www.valkee.com/about/science ], the Valkee user base has already grown to tens of
thousands of people in 20+ countries. Of all Valkee users, 87% recommend Valkee to others.
Additional tests and studies concerning the effects of bright light on cognitive and
physical performance and jet lag, among other areas, are ongoing and planned. Founded in
2007, Valkee headquarters are located in Oulu, Finland. For more information, please visit
http://www.valkee.com and follow us at http://www.facebook.com/valkeecompany and

http://www.twitter.com/humancharger.

        For further information, please contact:

        Pekka Somerto, CEO, Valkee
        Tel. +358-40-829-6343
        pekka.somerto@valkee.com

        Agency contact: Juha Frey, Netprofile for Valkee
        Tel. +358-9-6812-080 / +358-40-572-4674
        valkee@netprofile.fi

        Timo Takala, MD, Ph.D., scientific advisor
        Tel. +358-50-312-6902
        timo.takala@odl.fi

SOURCE Valkee


Source: PR Newswire