Ebb Insomnia Therapy: The Silver Bullet We’ve Been Waiting For?

The company name has changed. So has the wearable part of this sleep-promoting medical device.

But the product launch at selected sleep centers is still set for the final months of 2017, with full production capacity expected next year. Here’s an update on a device that will add to research-based treatment options for people with insomnia.

Ebb Insomnia Therapy helps people fall asleep more quicklyThe company name has changed. So has the wearable part of this sleep-promoting medical device.

But the product launch at selected sleep centers is still set for the final months of 2017, with full production capacity expected next year. Here’s an update on a device that will add to research-based treatment options for people with insomnia.

What It Is

The Ebb Insomnia Therapy device was developed by Ebb Therapeutics (formerly Cerêve, Inc.). Worn at night, it consists of a soft headband (rather than the plastic cap envisioned last year) attached by a tube to a temperature regulator that sits on a bedside table. Fluid is continuously pumped through the part of the headband that rests against the forehead, cooling it down. Research has shown that by cooling the forehead, the device reduces metabolic activity in the front part of the brain and hastens the onset of sleep.

Excessive Brain Activity at Night

The bane of many insomnia sufferers at night is a mind that keeps going and going and doesn’t want to stop. Such thinking and other executive activities (planning, decision-making) are functions of the frontal cortex, or the front part of the brain, involving the metabolizing of glucose.

Functional brain imaging studies—movies of processes occurring in the brain—have shown that the brains of normal sleepers are mainly quiet at night. No activity is detected in the frontal areas. In contrast, imaging studies conducted by Ebb Therapeutics founder Eric Nofzinger have revealed a great deal of metabolic activity occurring at night in the brains of insomniacs, including activity in the frontal cortex. Published images show that at night, the brains of people with insomnia are “lit up like Christmas trees.”

Cooling the Brain

Why might cooling the brain help? For starters, our core body temperature tends to rise in the daytime and fall at night. Previous research has shown that we tend to fall asleep more readily when our core body temperature is on the downward part of the cycle.

Two early studies conducted on people with insomnia showed that cooling the forehead at night

  • reduced participants’ core body temperature, and
  • reduced metabolic activity in the brain, particularly in the frontal cortex.

When Nofzinger and colleagues conducted a third, larger study (randomized and placebo controlled), they found that wearing the device significantly reduced the amount of time it took insomnia sufferers to fall asleep.

Compared With Current Insomnia Treatments

Many medications for insomnia have unwanted side effects. Ebb Insomnia Therapy is reported to have no appreciable side effects and classified as low risk by the FDA. As for its effectiveness, only time will tell how well it stacks up against insomnia drugs such as Ambien and Belsomra. New insomnia treatments like Ebb are only required to perform significantly better than sham treatment or placebo pill to gain FDA approval.

Cognitive behavioral therapy for insomnia (CBT-I), currently the gold standard in insomnia treatments, requires effort and commitment to a rigorous, weeks-long therapeutic process. Ebb Insomnia Therapy is relatively effortless. All it involves is wearing a headband at night. Some insomnia sufferers may begin to benefit right away, according to the company website. Others may take time to adjust to the device and need to use it anywhere from 2 to 4 weeks before seeing sleep improvements.

Limitations

The device will not be sold over the counter. It requires a prescription from a licensed physician or a licensed nurse practitioner. Nor has Ebb Therapeutics said how much it will cost. The company has taken out several patents, though, so the device will not be cheap. In addition, a new fluid cartridge will need to be purchased every three months. The device and cartridges are not expected to be reimbursable by health insurance companies anytime in the near future.

It’s doubtful the device will solve the sleep problems of every insomniac. The studies show that Ebb Insomnia Therapy reduces the time it takes to fall asleep and users report, after 30 days, that it improves sleep quality. Nowhere is the company claiming the device cuts down on night-time wake-ups or increases total sleep time, two items on the wish list of many insomnia sufferers.

Even so, it may be the silver bullet that at least some insomniacs have been waiting for. Particularly if you feel your sleep problem is driven by a yammering brain that just won’t stop, Ebb Insomnia Therapy is certainly worth checking out.

Cerêve Sleep Device Approved for Treatment of Insomnia

Would 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.

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?