In the two years since FDA clearance for the device, the sleep physician-founder has new insights on what subsets of people with insomnia may benefit from a prescription for the cooling therapy.
Ebb Insomnia Therapy, formerly the Cerêve System, is a prescription device that physically cools the foreheads of people with insomnia, thereby reducing frontal cortex activity and reducing latency to Stage 1 and Stage 2 sleep. The Food and Drug Administration (FDA) cleared it in mid-2016, and Ebb has since been made available to select sleep centers around the country.
The real-world data collected since the limited commercial launch has provided additional insights into what subsets of people with insomnia are most likely to achieve the greatest benefits from the device, says Ebb Therapeutics founder Eric Nofzinger, MD, a board-certified sleep physician, at the company’s booth at SLEEP 2018. These insights consider aspects ranging from the patient’s motivation to type of insomnia to experience trying the device in the medical facility.
Ebb works well with people who are motivated to change their behavior to improve their health, according to Nofzinger. For example, “people who have bought mattresses, tried to change their lifestyle, or tried to do something with sleep hygiene,” he says. “Those are the individuals who this product really works well and works with their lifestyle. If, on the other hand, somebody doesn’t think insomnia is a big problem or they really aren’t motivated to change their lifestyle to improve themselves, this is probably not the product for them.”
A challenge for some patients with insomnia who are prescribed sleeping pills is that the medications half-life typically precludes middle-of-the-night dosing, even when patients wake up and can’t fall back asleep. As a nondrug therapy, here Ebb has an advantage in treating sleep maintenance insomnia specifically. “With this device, the patient is in control of the duration of the therapy. As soon as they’re done using the device, they take it off. There are no lingering effects,” Nofzinger says.
For patients who suffer from sleep onset insomnia, Nofzinger notes that the device should be put on about 30 minutes before the person wants to fall asleep. He explains, “It’ll take about 10 or 15 minutes for the device to cool down. Then the relaxation response starts to kick in. Once they start to feel that, then they can get into bed and drift into sleep.”
Ebb can be used nightly for those who have insomnia every night or can be used on an as-needed basis for people whose insomnia is episodic.
Doctors should explain to patients the range of insomnia treatment modalities available, ranging from cognitive behavioral therapy to pharmaceuticals. “Through that discussion with the patient, they come to an understanding of what they want to try. We’re finding that people gravitate toward Ebb Insomnia Therapy if they want some type of physiological help with their hyperarousal,” Nofzinger says.
If Ebb seems like a good solution, Nofzinger recommends the patient put it on in the office for about 20 minutes. “We want to make sure the patient—before they go home with the device—they understand what the device is going to do, what it feels like, what kind of noise it makes, what the temperature is…to make sure they can tolerate the use of the device in their home.”
Ebb has found a high relationship with the patient’s experience in the office with the experience they will have at home.
Sree Roy is editor of Sleep Review.