The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people.

Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.

Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, noted that the authorization provides a low-risk option that utilizes digital technology.

And Peña wasn’t the only one to speak highly of the solution. “Disruptive and persistent traumatic nightmares associated with post-traumatic stress are significantly underreported and undertreated, and there are no consistently effective treatment options,” said General Peter Chiarelli, retired vice chief of staff of the U.S. Army. “A nonpharmaceutical intervention, such as the Nightware digital therapeutic platform that performs the necessary reconnaissance of the mind to identify and interrupt severe nightmare without waking the patient, has been long sought by the military. It represents a transformational step forward in how we can begin to better support our veterans and active service members suffering from this disabling condition.”

Grady Hannah, CEO of Nightware, told BioWorld that the device includes a physician-prescribed kit that includes an Apple Watch loaded with a patented artificial intelligence platform. That platform monitors the biometric pattern of an individual’s sleep cycle, pinpointing elevated sleep stress associated with nightmares. According to the company, the watch requires a learning period, typically less than 10 days.

The prescription-only Nightware is intended for home use; however, it is not a standalone therapy. The FDA emphasized that it must be used with prescribed medications, adding that those who act out during their nightmares – to include actions such as sleepwalking and violence – are not good candidates for Nightware.

Hannah noted that the solution will be available on a limited basis via prescription. The company expects a wide launch in the first quarter of next year. “Our first focus is on the Veterans Health Administration (VHA) health care system and the Department of Defense Military Health System (MHS) in order to reach military individuals with the most urgent need,” he explained when asked about availability.

“Each of these health systems has different product committee review cycles, during which new products and devices are reviewed, recommended for future use within their system as well as coverage and reimbursement rates.”

He added that the company is working to secure such reviews to get this option to those in need. At the same time, it is building out its sales force and commercial distribution partners, with an eye toward fulfilling demand at the time access determinations are finalized.

In terms of pricing, he noted that the costs will be determined via government insurance coverage associated with each aforementioned entity.

When asked about potential future geographies for the product, Hannah replied that the company hopes to make its option available globally. With that said, the U.S. remains its primary target, particularly with the de novo nod in hand.

Looking ahead to the next 12 to 18 months, the company remains committed to working through product committees within the military health system, with an eye toward helping both active service members and veterans. “We intend to expand availability to commercial insurance plans in the future,” he confirmed.

The company has pegged the number of patients with nightmare disorder at 5 million. Hannah noted that about 80% of PTSD patients experience frequent recurrent traumatic nightmares, which can persist for years. “Current treatments are limited and can have adverse events. In addition to a lack of approved treatment for PTSD-associated nightmares, the FDA’s blessing establishes that this is a serious public health issue and confirms the clinical benefit at a low level of risk for users.”

Clinical backing

In terms of clinical studies, the solution was assessed in a 30-day, randomized, sham-controlled trial of 70 patients. Those in the sham group wore the device, but no vibratory stimulation was provided. Safety was assessed using validated measurements of suicidality and sleepiness, and there were no changes in either over the course of the study in either group.

Meanwhile, the researchers looked at sleep with two versions of the Pittsburgh Sleep Quality Index scale, the self-rated questionnaire for assessing sleep quality, including a version of that scale that is intended for PTSD patients. While the sham group showed improvement, the active group demonstrated even more impressive results. As a result, the evidence demonstrated the probable benefits outweighed the probable risks.

Hannah said his company is expanding to a second clinical study site at the Tampa VA, eyeing the completion of its randomized clinical trial.