Med Device Monday: Cerêve Insomnia Aid

The American Academy of Sleep Medicine (AASM) says that some 30% of adults experience insomnia symptoms. So, chances are that most of us have at least a passing familiarity with the struggles associated with sleep difficulties. Inability to sleep well isn't just an inconvenience: it's a dangerous health issue. Per the AASM, side effects include moodiness and irritability, fatigue, lack of concentration, poor memory, poor quality of performance at work or school, and an increased risk for mistakes at work and driving accidents.

Despite the variety of solutions out there - cognitive behavioral therapy, prescription and over-the-counter drugs, meditation, good sleep hygiene, etc. - people still suffer from insomnia. Enter Cerêve, a medical device for insomnia that was recently approved via the de novo regulatory pathway. The product's website is pointedly short on details, but its Evaluation of Automatic Class III Designation (de novo), which can be found here, says it is a "...Thermal System for Insomnia: A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface. " 

According to Cerêve's website, founder Eric Nofzinger is a doctor who has been working with and treating patients with sleep disorders for most of the past 35 years. It also says he "pioneered the use of brain imaging tools for the study of sleep and its disorders in the early 1990s". Per Sleep Review Magazine, "The inspiration behind the Cerêve System came from functional brain imaging studies that Nofzinger conducted at the University of Pittsburgh. Patients with insomnia often describe “racing minds” that prevent them from sleeping soundly. The functional brain imaging studies confirmed that the frontal cortex, or executive brain, stays active in people with insomnia during sleep, preventing them from getting deeper, more restorative sleep. Nofzinger’s solution: gently cooling the forehead within a precise, clinically-proven therapeutic range in order to reduce this activity in the frontal cortex."

Lois Maharg at The Savvy Insomniac reports that the device is a cooling cap "...made of soft plastic, [which] comes with a software-controlled bedside device that continuously pumps fluid to a pad that rests against your forehead and cools the brain. You wear it all night." She goes on to relay this explanation from Nofzinger: "“Insomniacs have too much metabolic activity in the frontal cortex,” Nofzinger said. “It’s very soothing to be able to settle that brain activity” by cooling the frontal region of the brain."

At the time of publishing, there are no videos or images of this product to share. But a novel, non-invasive, low-risk product proven to help people overcome a common, dangerous health issue? I'm on board. I've said it here before, but seeing technology advance medicine is just so cool. 

Cerêve is not currently available, but per the above sources it's slated to be in the second half of 2017.