A fledgling Twin Cities company that uses Apple technology to gently interrupt the nightmares of those who suffer from post-traumatic stress disorder (PTSD) has begun to commercialize its NightWare product as an economical alternative to drug treatments.
The Food and Drug Administration last week authorized "a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares," said Carlos Peña, director of the FDA's Office of Neurological and Physical Medicine Devices.
PTSD is a disorder that affects some who have experienced combat or other shocking or dangerous events.
Though many treatments have been used to help treat PTSD, many involve drugs and some patients experience bad side effects or become dependent on them.
"PTSD is persistent and hard to treat. The less drugs the better," said NightWare CEO Grady Hannah, 47, a St. Paul native who has worked to commercialize NightWare since 2017. "This condition is life-threatening. Suicides."
The company's initial focus will be working with the Department of Veterans Affairs and the Defense Department, he said.
The company said the two departments combined are a $1 billion opportunity for NightWare. The VA spends $3 billion annually on PTSD treatments, not including drugs.
The global PTSD therapeutics market — including drugs — is projected to grow by $900 million from 2020 to 2024, according to Research and Markets.
"We have preliminary economic analysis that shows NightWare savings in treating someone with PTSD," Hannah said.
NightWare estimates that one-quarter of PTSD patients have nightmares; the VA estimates 50%, he said.
NightWare said it is the first company to focus on sleep as a partial cure for PTSD.
The firm, with five employees so far, has been funded by $2.3 million in equity investments and $100,000 from the Minnesota Department of Veterans Affairs.
NightWare also is in the hunt for more capital as it starts to scale commercially.
Hannah declined to estimate how much the NightWare-solution package would cost.
It will be available by prescription only and is intended for home use.
NightWare is a digital therapeutic that uses an Apple Watch and an Apple iPhone, configured and logged into a software application and the NightWare server.
The Apple Watch sensors monitor body movement and heart rate during sleep. The data are sent to the NightWare server and, using a proprietary algorithm, detects when a patient is experiencing a nightmare. The server then sends a signal for the smartwatch to provide vibrations.
The treatment was studied in a 30-day randomized trial of 70 patients, according to the FDA. Patients in a control group wore the device, but no vibratory stimulation was provided. Both the control and active groups showed improvement on the sleep scales, with the active group showing greater improvement.
In recent years, the VA and other therapists have introduced more non-drug treatments, from yoga and breathing, to counseling.
And exhaustion has been shown to impede good mental health.
NightWare was created through a 2015 technology innovation contest by a 21-year-old Macalester College student, Tyler Skluzacek. His father, a member of the Minnesota National Guard, was disabled by PTSD after returning from a combat deployment to Iraq in 2005 and 2006.
Hannah, an entrepreneur and Silicon Valley veteran, read the Star Tribune account and contacted Skluzacek, who further developed the device and is an adviser to NightWare.
Justin Miller suffered PTSD after returning home to South Carolina from two combat deployments in Iraq as part of a sniper team. He said in 2019 that he would wake nightly in a sweat with a racing pulse. Sometimes he would flail about.
The NightWare app helped him sleep through the night. He reduced his consumption of energy drinks, melatonin to help with sleep, and even his antidepressant dosage, he said.
"Once I started sleeping, it's amazing how much the rest of my life changed," he said. "I have more patience. I am able to keep my cool, most of the time. I didn't know [sleep] was possible anymore. It hadn't happened in years."