Placebo-controlled trial of Ebb Insomnia Therapy publishes in the official journal of the Sleep Research Society
A clinical study of a new, drug-free insomnia treatment has published in SLEEP, the official publication of the Sleep Research Society, an organization for scientific investigators who educate and research sleep and sleep disorders. Results of the study, which tested Ebb® Insomnia Therapy, showed a statistically significant reduction in latency to Stage 1 sleep, the time it takes to get into the first stage of sleep, as well as latency to Stage 2 sleep, a deeper stage of sleep that typically represents over half the night
Conducted at seven clinical sites across the U.S., the SLEEP study included a randomized, placebo-controlled trial collecting polysomnographic sleep measurements in 106 adults with primary insomnia. Authors of the study included Thomas Roth, Ph.D.; David Mayleben, Ph.D.; Neil Feldman, M.D.; Alan Lankford, Ph.D.; Timothy Grant, M.D.; and Eric Nofzinger, M.D.
Protected by nine issued and 25 pending patents, Ebb Insomnia Therapy is a software-controlled bedside device that cools and pumps fluid to a forehead pad that is worn through the night. The device is also the only drug-free insomnia treatment cleared by the FDA that reduces the time it takes to both fall asleep and enter deep, restorative sleep.[i] The inspiration behind Ebb Insomnia Therapy came from pioneering functional brain imaging studies conducted at the University of Pittsburgh by Eric Nofzinger, M.D., Founder and Chief Medical Officer at Ebb Therapeutics™.
In total, three independent clinical studies conducted over 3,800 research nights demonstrated the safety and efficacy of this novel device, with an extremely low incidence of adverse events.[ii] Ebb Insomnia Therapy’s safety profile compares favorably to that observed for approved prescription drugs for insomnia, which have the potential for dependence, memory loss, confusional arousals, sleep-walking and problems with coordination that increase the risk of middle of the night falls and fractures in the elderly.
Patients who used Ebb Insomnia Therapy reported improved quality of sleep after 30 days of in-home use and found it was easy to use and wear, creating a calming and comfortable experience. Ebb Insomnia Therapy has also been found to be safe over six months of in-home use.
“With our pivotal clinical study now publishing in SLEEP, it is wonderful to see the strong data to authenticate our hard work and support Ebb Insomnia Therapy’s clinical effectiveness,” said Dr. Nofzinger. “This device is truly ground-breaking and can impact the lives of so many, helping them fall asleep faster and enter deeper sleep, all in a safe way that can reduce dependency on other drugs.”
Currently, Ebb Insomnia Therapy is available by prescription at 17 sleep centers and sleep specialist offices across the country, in Delaware, Georgia, Kansas, Maryland, Missouri, North Carolina, North Dakota, Ohio, Pennsylvania and Texas. Availability is expanding rapidly, with complete national availability of the treatment expected by early 2019.
[i] The Food and Drug Administration cleared Ebb Insomnia Therapy as a class II medical device indicated to reduce sleep latency to Stage 1 and Stage 2 sleep in patients with primary insomnia based on a de novo clearance request. Ebb is a prescription device.
[ii] Most common adverse event was headache in both therapy and placebo group and all were resolved without intervention.
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