This study was funded by grants from the National Heart Lung and Blood Institute (grant numbers 1R43HL097537 and 2R44HL09753) and by the device manufacturer, Ebb Therapeutics, which provided all devices used in this study. Additional supporting analyses of objective and subjective sleep measurements were also carried out to further clarify the clinical significance of the device in treating sleep disorders. These results show that acute treatment over two nights with a novel medical device that provides frontal cerebral heat therapy improved objective measures of sleep induction in patients with sleep disorders compared to a dummy device, increased sleep duration in the first hour of the night and was associated with a benign safety profile. One challenge for some patients with sleep disorders who are prescribed sleeping pills is that the half-life of the drugs usually precludes administration in the middle of the night, even if patients wake up and are unable to fall back asleep.
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