HumanCharger Headset Reduces Jet Lag Symptoms in World's First Placebo-Controlled Clinical Field Trial With any Bright Light Device
HELSINKI, June 10, 2015 /PRNewswire/ --
World's First Double-Blind Placebo-Controlled Light Therapy Device Field Study
Published in the Peer-Reviewed Journal Aerospace Medicine and Human Performance:
HumanCharger Reduces by Approximately 50% the Time Needed for Full Jet Lag Recovery
The Finnish light therapy headset maker Valkee (http://www.valkee.com) today reports the publication of a clinical field study on reducing jet lag symptoms after long haul flights with HumanCharger (http://www.humancharger.com), the CE-marked medical device for reducing jet lag symptoms. The study explored effects of non-ocular bright light channeled via ear canals onto the photosensitive brain regions in four daily 12-minute light doses during transatlantic travel across 7-10 time zones and for 7 days in maximum at destination.
In the study, the treatment group (n=25) recovered fully from the typical jet lag symptoms approximately in half of the time compared to the placebo group (n=30). The average time needed for symptoms to resolve was 3-4 days for the treatment group and over 7 days for the placebo group. Similarly, 83% of treatment group became symptoms free during the post-flight measurement period, compared to the 55% in the control group. The results were statistically significant (p=0.0380).
The results of the HumanCharger clinical trial were published in Aerospace Medicine and Human Performance, the peer-reviewed monthly journal published by the Aerospace Medical Association (AsMA). The journal is the most used and cited journal in its field. The HumanCharger clinical jet lag trial publication can be downloaded from HumanCharger site.
The placebo-controlled double-blind study on jet lag recovery with bright light via the ear canal was the first successful clinical jet lag field study with a medical device. It was also the first fully double-blinded jet lag study with a bright light therapy device. In the study, the light-emitting earplugs were fully covered and their light emitting functionality controlled to avoid any cues on randomization between the placebo or treatment group.
About the present study
Participants in the HumanCharger field study were 55 healthy volunteers, who flew from Finland to North America and back and spent at least one week on the ground in North America before their flight back, to allow their internal clock to adjust into the US time. The encountered time difference varied from 10 hours (from US west coast) to 7 hours (from US east coast).
Immediately after returning to Finland, jet lag symptoms were measured daily using several well-established questionnaires: Karolinska Sleepiness Scale (KSS), Horne-Östberg Morningness-Eveningness Questionnaire, Visual Analogue Scale (VAS), State Trait Anxiety Inventory and Profile of Mood State (POMS). The effects of treatment were evaluated by the same structured scales, which were used in all seven jet lag field studies that have been published during the last 15 years.
A significant difference was measured between the HumanCharger and placebo group for VAS for overall jet lag symptoms, as well as for subjective sleepiness (KSS) and in POMS scores for feelings of fatigue, inertia, and forgetfulness. None of the 55 subjects in the present study reported any adverse effects as a result of the HumanCharger treatment.
Based on the study results and other required qualifications, HumanCharger was granted in April 2015 the EU medical device CE-certification under Council Directive 92/43/EEC.
About Valkee
Valkee is a medical device and technology company with a mission of harnessing the health and wellness benefits of light for the human mind and performance. Based on long-term scientific research and development work together with Finland's Oulu University researchers, Valkee introduced the world's first bright light headset in 2010 for treatment of Seasonal Affective Disorder.
To date, placebo- and sham-controlled studies have confirmed that light modulates brain activity and shown the efficiency of the ear canal as a channel for projecting light to photosensitive areas of the human brain.
For more information:
Contact CEO Aki Backman at +358-40-1239872 or aki.backman@valkee.com and visit
Link to view the full article: http://www.humancharger.com/r/study
Photo gallery: http://www.humancharger.com/r/photo
The HumanCharger jet lag app for managing the correct timing of light exposure is available now free of charge through this shortcut and QR code: http://www.humancharger.com/r/qg-to-jla/
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