Patients with insomnia, the frontal cortex stays active, preventing them from getting deeper, more restorative sleep. These patients often describe a “racing mind” that interferes with getting a sound sleep.
Gently cooling the forehead within a precise, clinically proven therapeutic range reduced this activity in the frontal cortex. The new software-controlled bedside device cools and pumps fluid to a forehead pad that is worn throughout the night. Three clinical studies that included more than 230 patients over 3800 research nights demonstrated the safety and efficacy of the device. In one of these — a randomized, placebo-controlled trial of people with primary insomnia at seven clinical sites across the United States — results from polysomnographic sleep measurements showed a statistically significant reduction in latency to stage 1 sleep, the time taken to get into the first stage of sleep, as well as latency to stage 2 sleep.
This is the first and only insomnia device cleared to reduce sleep latency to stage 1, the first stage of sleep, as well as stage 2, a stage of sleep that typically represents over 50% of the sleep period.