Tags: insomnia | sleep | disorders | device | FDA

FDA Approves New Sleep Device

FDA Approves New Sleep Device
(Copyright DPC)

Friday, 10 June 2016 11:16 AM

The U.S. Department of Food and Drug Administration (FDA) has approved a new prescription device designed to enable people with insomnia to sleep better.

The device, called the Cerêve Sleep System, is designed to induce better sleep by keeping the forehead cool, the company says.

According to the company, the inspiration behind the new device came from functional brain imaging studies conducted by Eric Nofzinger, MD, a board-certified sleep physician and founder of Cerêve, at the University of Pittsburgh.

These studies confirmed that in 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.

The device 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, the company says.

Roughly 60 million Americans suffer from chronic insomnia, which is characterized by difficulty in falling or staying asleep. The disorder mostly affects people over the age of 60.

The device is expected to be available with a prescription in 2017.

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A new device to aid the 60 million people who suffer from insomnia has won federal approval and is to be marketed next year.
insomnia, sleep, disorders, device, FDA
Friday, 10 June 2016 11:16 AM
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