A clinical study of a new, drug-free insomnia treatment was published on April 10, 2018 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.
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.* 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.”