The FDA has given NightWare clearance to market a “digital therapeutic” device that uses an Apple Watch to interrupt PTSD-related nightmares.
COURTESY OF NIGHTWARE
EVERY NIGHT, PATRICK Skluzacek woke with his heart pounding and his T-shirt drenched with sweat. The details of his nightmares often slipped away when he snapped his eyes open, but he knew their broad strokes. He was back in the Iraq War, trekking to or from the hellish insurgent stronghold of Fallujah, alert to ever-present danger as he commanded a convoy of fuel tankers to supply a Marine base. Even years after he returned home, his racing mind couldn’t adapt to the calm of civilian life.
After a while, the fear of the nightmares became more destructive than the nightmares themselves. Skluzacek recalls trying to obliterate them with antidepressants, anti-anxiety meds, sleeping pills, and increasing quantities of alcohol. Nothing worked for long. The nightmares returned like a nightly horror show. He figures he was getting about two hours of sleep a night.
Skluzacek’s life went into a downward spiral—he got divorced and lost his job as a mechanic—and he struggled to persevere. Then in 2015, eight years after Skluzacek returned from the war, his son Tyler had an idea.
Tyler Skluzacek, then a senior at Macalester College in St. Paul, Minnesota, imagined programming a smartwatch to monitor and disrupt nightmares. He entered HackDC 2015, a 36-hour hackathon dedicated to finding innovative ways to help people with post-traumatic stress disorder. His team programmed a Pebble watch (an early but now-defunct wearable) to measure heart rate and body movements during sleep. It would send vibrations to the wearer’s wrist when those indicators increased, signaling the beginning of a nightmare. The younger Skluzacek got his idea from the work of service dogs, who lick or nudge veterans with PTSD who are thrashing or moaning in their sleep, to disrupt their nightmares and allow them to sleep more peacefully. The day after he returned home from the hackathon, Tyler brought the prototype to his father. “I was literally building the thing for my dad,” he says. “On the ride home, I had no intention of turning this into a company.”
Upon hearing that this son wanted to help, the elder Skluzacek cried. Then he began wearing the device. “I slept like a baby,” says Patrick, who has since remarried and is now working as a mechanic again. His nightmares are mostly gone, and he no longer uses the device.Cyber Week Starts Now.Get WIRED for $10 $5.
Now an updated version may help thousands of other veterans get a better night’s sleep. The Minneapolis-based startup NightWare developed Tyler’s concept, raising investment funds, partnering with the Minneapolis VA Medical Center, and conducting a clinical trial. The “digital therapeutic system” uses the sensors on a specially programmed Apple Watch to create a baseline sleep profile of the wearer. The sensors then can detect the rising heart rate and body movement associated with troubled sleep. The watch delivers vibrations in cycles of 10 seconds, increasing in intensity to arouse but not awaken the wearer, until the metrics ease back to normal levels.
The first hint of the high demand for such a device came when Tyler Skluzacek’s team won “Best Mobile Application for Clinicians” at the hackathon. The ensuing news coverage sparked emails from hundreds of veterans. He launched a Kickstarter campaign to raise $1,200—and raised $26,000. At first, he called the device MyBivy, in reference to the bivouacs, or compact shelters that combat soldiers use to protect themselves at night, and he tested it on other veterans.
Grady Hannah, who spent 15 years in Silicon Valley and worked in business development in the video game industry, had moved back to his hometown of Minneapolis when he saw news coverage of Tyler’s hackathon success. He initially became an adviser to MyBivy, then purchased the rights from Tyler to create NightWare, and is currently the company’s CEO. (Tyler is still a consultant to NightWare but doesn’t have a formal role in the company.)
On November 7, the US Food and Drug Administration gave NightWare clearance to market the “digital therapeutic” device as a new treatment for PTSD-related nightmare disorder, which is defined as repeated, extremely dysphoric dreams that cause anxiety or affect daytime functioning. The FDA granted NightWare “breakthrough device” status, which allows for swifter review of devices designed to treat life-threatening or irreversibly debilitating disorders. PTSD is considered one of those disorders, because it has been associated with an increased risk of suicide and can cause persistent symptoms that are difficult to treat. (In the announcement of its authorization, FDA officials noted that NightWare is not a “stand-alone therapy” for PTSD nor a replacement for a patient’s existing PTSD medications and therapy.) In early 2021, NightWare will be available by prescription through the Veterans Administration and US Department of Defense health plans, free of charge to the wearers, who will be veterans or members of the military. It will not initially be available to the broader public, says Hannah.
“Nightmare disorder tends to be one of the most invasive parts of PTSD, because you can’t escape it,” says Hannah. “Imagine every night reexperiencing the worst moment of your life.”
In the FDA application, NightWare provided unpublished data on a group of 70 veterans, which is part of an ongoing study conducted in partnership with the Minneapolis VA Medical Center. It showed that the device improved self-assessed sleep quality more than a sham device or prazosin, a hypertension medication often used to treat frequent and disruptive nightmares. The study will ultimately enroll 240 veterans.
Everyone has the occasional nightmare—most commonly scary sensations of falling or being chased. The most vivid of those “ordinary” dreams and nightmares occur during REM sleep, when we process emotions and memories. Researchers don’t fully understand the mechanism of dreaming, but brain imaging shows activity in the amygdala and hippocampus regions (involved in processing emotions, fear, learning and memory), similar to what is seen during waking experiences.
But about 4 percent of Americans have nightmares that are recurring and distressing, wrecking sleep and impairing daily functioning. Nightmare disorder often follows a traumatic event and can be just one aspect of PTSD, although it also can be an independent psychiatric disorder.
Flashbacks during the day and recurring nightmares may be waking and sleeping versions of the same phenomenon, in which traumatic memories get stuck in narrative, or short-term, memory and don’t fade as other memories do, says Deirdre Barrett, a Harvard Medical School psychologist who has devoted her career to studying dreams. She hypothesizes that traumatic nightmares are a holdover from our hunter-gatherer days, when a near-mauling by a tiger that suddenly appeared on the savannah would be something vital to remember. “Bad things that could happen were very likely to happen again soon, and it was adaptive to stay scared,” she says.
In modern times, staying stuck in a horrific moment just brings lingering terror and fatigue. Memories of extreme events, such as the 9/11 terrorist attacks or Hurricane Katrina, inevitably disrupt sleep and invade the dreams of those who lived through the trauma. As the Covid-19 pandemic began to unfold, Barrett began collecting reports of vivid dreams and nightmares, which she published in a book, Pandemic Dreams. About 600 of the more than 9,000 dreams she gathered from around the world came from health care workers. They dreamt of patients with airways too constricted to intubate, ventilators that didn’t work, and patients who died despite their intense efforts. Their descriptions were all too real, even if they contained surreal images (such as a ventilator that morphed into a water cooler).
Image rehearsal therapy is widely accepted as an evidence-based treatment that helps people literally rewrite the nightmare scenario. Just thinking about more pleasant images and a happy ending while awake can seed a substitute dream. Other non-drug treatments include relaxation techniques, hypnosis that gives patients a pathway to deep relaxation before falling asleep, or cognitive behavioral therapy to work through the trauma and anxiety.
Yet nightmares can persist as part of the constellation of anxiety-related symptoms of PTSD, causing significant distress, says Bhanu Kolla, a psychiatrist and sleep specialist at the Mayo Clinic in Rochester, Minnesota. “In the context of post-traumatic stress, nightmares become harder to treat,” he says.
Kolla recalls seeing a Minneapolis Star-Tribune article about the Skluzaceks and the development of the original MyBivy device. “Excellent theory,” he says. But before he endorses such an approach, he says, “I’m going to wait until I see peer-reviewed data [in a published study] showing that it does help reduce frequency and intensity of nightmares and improve the quality of daytime functioning.”
Barrett, who is not familiar with the NightWare device or research, says she can see how it could provide relief from distressing dreams. But she also wonders if it would shift people into the more shallow stage 2 sleep, compared to REM sleep, in which the most vivid dreaming occurs. “The amount of time spent in REM sleep is beneficial to social functioning and creativity [and] emotional memory,” she says.
As part of its FDA submission, the researchers working with NightWare assessed safety compared to a sham device. Neither the real or sham device led to changes in suicidality or sleepiness. (The researchers didn’t measure time spent in different stages of sleep.)
NightWare researchers continue to gather data on the device, and the company will soon open a cloud-based data repository that will enable clinicians to track the wearer’s sleep metrics. The Center for Medicare and Medicaid Services is considering adding Medicare “coverage of innovative technology” for devices that have FDA breakthrough status, which would open up a new market in addition to veteran and military users.
In the meantime, Tyler has moved on to new challenges. He’s pursuing a doctorate in high-performance computing at the University of Chicago. “Honestly, it feels good,” he says of knowing that his nightmare-disrupting idea will soon be available to veterans with PTSD. “Sometimes you go off with a one-in-a-million shot of an idea. You might not think it will pan out.” But in this case, he far exceeded his goal of helping his dad get a good night’s sleep.
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