Patients experiencing insomnia may reach for over-the-counter (OTC) or prescription sleep aids to help them fall asleep but physicians at Ebb Therapeutics believe that a drug-free treatment may be a safer way to address sleeping troubles. The company has developed an FDA-approved medical device – called Ebb Insomnia Therapy – that aims to lessen uncontrolled thoughts that can impede a person’s ability to sleep, by cooling the frontal cortex.
The technology behind the device was presented at the 31st annual meeting of the Associated Professional Sleep Societies conference, known as SLEEP 2017. Attendees of the meeting had the chance to experience the technology that has been shown to reduce the time it takes for patients to reach the first stage and deeper stages of sleep, known as Stage 1 and Stage 2.
“Patients with insomnia often describe ‘racing minds’ that prevent them from sleeping soundly,” said Dr. Eric Nofzinger, Founder and Chief Medical Officer at Ebb Therapeutics. “My 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. Our clinical studies have demonstrated that by gently cooling the forehead within a precise therapeutic range, Ebb Insomnia Therapy allows insomnia patients to fall asleep faster.”
The Ebb Insomnia Therapy medical device is worn like a headband. A bedside unit connects to the headpiece and continuously pumps cooled fluid into the wearable throughout the night.
Nofzinger developed the device and founded Ebb Therapeutics after conducting functional brain imaging studies at the University of Pittsburgh. The safety and efficacy of the medical device were demonstrated in three independent clinical studies.
Of note was a pivotal clinical study which involved 106 adult patients with primary insomnia across seven clinical sites in the US. Patients were randomly assigned to receive two nights of therapy with the medical device, or a placebo.
Using polysomnographic sleep measurements, which monitor brain function, the researchers found that adults using the insomnia medical device showed a statistically significant reduction in the latency to both Stage 1 and Stage 2 sleep. Stage 2 sleep is a deeper phase that usually lasts over half the night.
Patients who tried Ebb Insomnia Therapy at homes reported that the medical device was easy to wear and resulted in better quality sleep after 30 days of use. Ebb Therapeutics reports that the device is safe for recurrent use over six months.
“Knowing 55 million Americans are living with insomnia, Ebb Therapeutics is working diligently to bring our new technology to market to relieve the suffering experienced by so many,” said Don Spence, CEO at Ebb Therapeutics. “Sleep is a vital pillar of health, along with diet and exercise, yet the current therapeutic options available to physicians and insomnia patients are limited, many leading to unwanted side effects. Ebb Insomnia Therapy is safe, free of significant side effects and will address an important clinical need by quieting the racing minds of insomnia patients, helping them fall asleep faster and get the rest they need to take on tomorrow.”
In January, Ebb Therapeutics (formerly Cerêve) raised $38 million in Series B financing to support the launch of the medical device. According to Ebb Therapeutics, select sleep centers will have access to the medical device later this year, with national available to start in 2018 after manufacturing efforts have been increased.