new insomnia treatment approved by FDAWould you wear a cap at night if it helped you fall asleep faster?

You may soon have the opportunity: the cap, a medical device for the treatment of insomnia, has received approval from the FDA, clearing the way for it to come to market.

“We are thrilled that the FDA has cleared the Cerêve Sleep System for treating people with insomnia,” sleep specialist and company founder Eric Nofzinger was quoted as saying in a press release. “The Cerêve System offers a clinically proven and safe alternative to pills, with the potential to help millions of Americans get to sleep fast.”

A Novel Insomnia Therapy

It isn’t just any old cap. This cap, made of soft plastic, 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.

I found out about the cap and the cooling process—called frontal cerebral thermal transfer—at a conference on sleep and sleep disorders in 2011. My first reaction was disbelief. Really? I said to myself. Now they’re proposing to cure my insomnia by sticking an ice pack on my brain? No way!

Despite my skepticism, I showed up for a poster session where Nofzinger was talking about results of clinical trials conducted on insomniacs who used the device at night. Patients responded positively, he said. “They describe it as sort of like a spa treatment.”

But what did wearing a cooling cap have to do with insomnia? I asked him. What was the relationship between the two?

“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. “It’s as if your grandmother put a washcloth on your forehead.”

Something cold against my forehead sounded unappealing, I told him. I can’t sleep when I’m cold.

The temperature can be adjusted within a comfortable range of coolness, was Nofzinger’s response.

Origin of the Concept

Formerly, Nofzinger directed the Sleep Neuroimaging Research Program at the University of Pittsburgh School of Medicine. He and his colleagues studied neural activity in the human brain. What they knew from past studies was that the brains of normal sleepers are largely quiet at night: there’s not much metabolizing of glucose. But in functional brain imaging studies of insomnia patients, the researchers saw something different.

In insomniacs at night, quite a bit of glucose was being metabolized in certain areas of the brain, especially the frontal cortex (the part responsible for thinking, planning, and other executive functions). Excessive activity in the frontal cortex might be a biomarker of the hyperarousal believed to underlie insomnia, and decreasing this activity by gently cooling the frontal lobe might lead to sounder sleep.

Testing the Device

Once the device was created, it had to be tested for safety and efficacy on insomnia patients. The first two studies were small and the main results were as follows:

  • The devices reduced brain metabolism during sleep, especially in the frontal cortex.
  • They also reduced participants’ core body temperature (also favorable to sleep).
  • The cooler the setting, the greater was the benefit.
  • Worn all night at the coolest setting, the devices enabled insomnia patients to get to sleep as quickly and sleep as efficiently as normal sleepers.

A third much larger clinical trial—randomized and placebo controlled—was conducted with funding from the National Institutes of Health. The caps were found to reduce the time it took insomniacs to reach Stage 1 and Stage 2 sleep, effectively helping them fall asleep faster. Regarding safety, Cerêve Sleep System was classified by the FDA as a novel, low-risk device.

Now that the FDA has granted its approval, what remains to be done is to ramp up production and roll out a marketing campaign. These things always take more time than you’d like them to, but as of now Cerêve expects to launch the product in the second half of 2017.

Does this sleeping cap sound like something that might help your sleep? Why or why not?

Posted by Lois Maharg, The Savvy Insomniac

Lois Maharg has worked with language for many years. She taught ESL, coauthored two textbooks, and then became a reporter, writing about health, education, government, Latino affairs, and food. Her lifelong struggle with insomnia and interest in investigative reporting motivated her to write a book, The Savvy Insomniac: A Personal Journey through Science to Better Sleep. She now freelances as an editor and copy writer at On the Mark Editing.

13 Comments

  1. Sounds exciting! I will definitely try it when available

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  2. I will definitely try it.

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  3. In most Autogenic Training exercises, in addition to learning to induce in oneself the sensations that “my feet/ankles/legs/etc are getting heavier/warmer”, there is an notable exception: “My forehead is becoming COOLER”. AT was developed by a psychoneurologist in Germany @ 1920 who wanted to generalize the results of hypnosis. I find it an interesting coincidence that AT wants the Forehead COOL, and the new device described here physically induces more or less the same thing.

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    1. That IS interesting, and probably not coincidental. Body temperature, relaxation, sleepiness—all are related. These two therapies, different as they are, are aimed at helping people achieve a state of relaxation and repose. Thanks for pointing out the similarity.

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  4. I definitely want to give this a try.

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  5. Sounds like something relatively easy to simulate ourselves with a padded ice pack, perhaps already partially defrosted. It wouldn’t last all night but could be used to see if it helps you fall asleep.

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  6. I would be curious to try an ice pack on my forehead the next time I can’t fall back asleep (which is literally every night).

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  7. Yes, I would like to try it. I do not like taking pills. It sounds like it is publicly funded research and development. University of Pittsburg and then National Institute of Health? Hope they don’t try to gouge the public who help bring it to market.

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    1. Hello Julie,

      Here’s what the company’s most recent press release says about the funding of the research: “Cerêve was funded in part by a grant from the National Institute of Health as well as by venture capital firms Arboretum Ventures, Versant Ventures and Partner Ventures.”

      I don’t have a clue about how much these devices will cost once they come on the market.

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  8. I am looking forward in trying it.

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  9. I need a full body cooling suit…Im like a human furnace….looking forward to seeing if this comes to market!!!

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  10. Do you think trying a cold rag or a cold gel pack on the forehead might work in the meantime?

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  11. Hi Alex,

    Well, Dr. Nofzinger has compared the feeling of this new sleeping cap to a cool washcloth on the forehead. So maybe a cool rag or a gel pack might help, at least for a time. But for me the idea is not very appealing in the wintertime—my bedroom’s just too cold. I could see trying it, though, when the weather gets warmer.

    Thanks for writing in!

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