New FDA Approved Device for Insomnia May be More Effective Than Drugs

New FDA Approved Device for Insomnia May be More Effective Than Drugs

Resource Type
Report or Study
Medscape reported that the FDA provided clearance for an insomnia reducing device called the Cereve Sleep System to be sold in the U.S. It's design suggests it could have application for some people with chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM).

With almost 80% of the respondents in Health Rising's Sleep Survey reporting that the insomnia was a major or moderate problem, anything that helps ME/CFS or FM patients get to sleep more quickly and deeply would obviously be a boon.

Currently sleeping pills are the treatment of choice for most of the 55 million people in the U.S. with insomnia, but sleeping pills tend to diminish alertness, can lose potency over time, and can have other side effects.

[/fright]The Cevere Sleep System inventor, Eric Nofzinger, M.D., is a board-certified sleep physician and published researcher. In 2011 Nofzinger produced a hypothesis paper "A Neurological Model of Insomnia" that used brain imaging studies to explain insomnia differently. Nofzinger's was the first model that didn't focus on psychological-behavioral issues. Instead it posited that persistent activation of the neural structures that produce "wake-like" states were stopping people from quickly attaining deep sleep.

In the paper he defined insomnia in a way that may fit many people with ME/CFS/FM. Insomnia is not just difficulty falling asleep; it also incorporates "repeated awakenings with difficulty returning to sleep, or sleep that is non-restorative or poor in quality, often accompanied by the perception of short overall sleep duration."

Unrefreshing sleep is a common finding in chronic fatigue syndrome and fibromyalgia. Apparently, the model also includes people who can go to sleep quickly but have trouble reaching deep sleep.

Nofzinger stated that in "deeper, more restorative sleep, the depth of our sleep was connected to how successful our brains were in quieting down, so to speak, especially in the parts of our brains that controlled our working minds."

The Cevere Sleep System website emphasizes that the goal of the device is "calming the overactive mind", and the mental "hyperarousal" that is keeping many people from quickly entering into deep sleep.

ME/CFS/FM researcher Jarred Younger has explained that the brain heats up slightly when it becomes more active. Nofzinger's solution was simple. If the front part of the brain was "heating up", Nofzinger would cool it down using a device that pumped cooling fluids to a pad that fit on one's forehead.

Three studies, hundreds of patients and thousands of sleep lab nights later, studies indicated that Nofzinger had produced the first device that not only reduced the time it took (sleep latency) to enter into the first stages of sleep but into the second stages as well.

The Cerêve Sleep System is expected to become available during the second half of 2017. It was developed using funds from an NIH grant and with venture capital. If you're interested in the device you can sign up to get more information as it become available on the website below.
Health Rising is not affiliated with The Cevere Sleep system in any way.
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