FDA Clears Sleep Device for Insomnia

FDA Clears Sleep Device for Insomnia

System cools hyperactive frontal cortex

The FDA has granted commercial clearance for the Cerêve Sleep System, a prescription device that reduces latency to stage-1 and stage-2 sleep for people with insomnia.

Functional brain-imaging studies have shown that the frontal cortex, or executive brain, remains active in people with insomnia during sleep, preventing them from getting deeper, more-restorative sleep. The Cerêve Sleep System consists of a software-controlled bedside device that cools and pumps fluid to a forehead pad that is worn through the night. The pad cools the forehead within a clinically proven therapeutic range to reduce hyperactivity in the frontal cortex.

Three studies conducted in more than 230 patients over 3,800 research nights demonstrated the safety and efficacy of the Cerêve device. The company’s pivotal clinical study was a randomized, placebo-controlled trial of people with primary insomnia at seven clinical sites in the United States. Results from polysomnographic sleep measurements of subjects in sleep laboratories (the gold standard for evaluating sleep) showed a statistically significant reduction in latency to stage-1 sleep; in the time it takes to get into the first stage of sleep; and in latency to stage-2 sleep. In two additional studies, self-reports from patients indicated that the quality of their sleep improved during 30 days of in-home use of the Cerêve Sleep System.

The FDA evaluated the company’s application under a de novo classification for novel, low risk devices.