Is NightWare effective in reducing sleep disturbances and lowering cardiovascular risk for people with PTSD?

The NightWare device, developed to improve sleep for people plagued by PTSD-related nightmares, is now being studied as a possible tool for improving heart health in people with the disease.
Jan. 24, 2023
Research is underway to test whether NighWare can help people who experience nightmares related to Post traumatic stress disorder (PDSD), which is often seen in veterans like this soldier hugging his daughter.
Research is underway to test whether NightWare, a sleep technology, can reduce cardiovascular disease risk in people with PTSD. Photo: Getty Images

For some 20 years, Professor Kerrie Moreau, Ph.D., studied the physiology of cardiovascular aging: the processes that stealthily prod the blood vessels to stiffen and clog with plaque and the heart’s pumping power to diminish. For example, she’s probed the roles of sex hormones in that process, with an eye toward determining how they might be modified to prolong life.

In recent years, Moreau, professor of Geriatric Medicine at the University of Colorado School of Medicine, has also trained her attention on how psychological stress and trauma might also accelerate cardiovascular decline.

“We study the underlying biology that increases the susceptibility for blood vessel health to deteriorate,” Moreau says. “But how do life stressors contribute to that?”

A photo of Kerrie Moreau, who is helping to conduct a study on NightWare.
Kerrie Moreau, PhD

Working as a research health scientist at the VA Eastern Colorado Health Care System, Moreau has seen many men and women struggling with the effects of post-traumatic stress disorder (PTSD): a reaction to a disturbing event that brings lingering psychological challenges well after a person has experienced it. She is interested in exploring the possible physical consequences of PTSD. It’s far from idle speculation. The Veterans Administration, for example, is keenly interested in the question, noting that studies have linked PTSD to an increased risk of developing cardiovascular disease.

Moreau is now delving into the possible connection. She leads a National Institute on Aging-funded study of a device approved in 2020 by the FDA to help treat people with PTSD who suffer from sleep disturbances caused by nightmares. Moreau’s study aims to determine if the device, called NightWare, can also help to reduce stiffness in arteries and improve blood pressure, heart rate and other nervous system functions.

NightWear collects data in an effort to improve health

NightWare is a “prescription digital therapeutic,” meaning it uses mobile technology, such as a phone or tablet, and must be prescribed by a health care provider (no free downloads). Individuals are prescribed an iPhone and an Apple Watch equipped to monitor and collect information about body movement and heart rate while they sleep.

The idea is that the data, gathered over time, helps the system to establish a NightWare user’s sleep patterns and build a profile of a typical slumber. When the system detects disruptions to the pattern that could be signs of a nightmare – tossing and turning or rapidly quickening heart rate, for example – the watch vibrates, jogging the individual from the sleep turbulence without waking them.

A photo of Ryan Holliday, who is helping to conduct a study on NightWare.
Ryan Holliday, PhD

The potential benefits of simply sleeping better for a person with PTSD are enormous, Moreau said. Good sleep restores both mind and body, which improves quality of life. A rested person is more likely to exercise, she added. “Collectively, better sleep may help with depression, substance use disorders and cardiovascular health.”

Whether sleep improvements drive positive changes in the body’s processes is the fundamental question of Moreau’s randomized study, which is now underway. It aims to enroll 50 people, half of whom will receive the NightWare device, the other half a “sham” that is not enabled.

Participants must be diagnosed with PTSD, using criteria from the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). In addition, they will complete at-home sleep studies, both before and after the trial, to gauge changes in sleep patterns.

The study will glean data about possible physiologic and biologic changes among participants, as well as information about quality of life, suicide risk and depression symptoms.

Addressing an epidemic of stress and trauma

Moreau said that as soon as she learned of the FDA’s approval of NightWare in November 2020, she reached out to the company, which responded favorably to exploring whether it could be used to help people with PTSD decrease their cardiovascular risk.

She added that she immediately saw that the usefulness of the device could extend well beyond the veterans’ community. The COVID-19 pandemic was creating enormous stress on front-line health care workers, as well as friends and families of patients. Other societal pressures have continued to mount, she added.

“We have COVID-19, natural disasters, mass shootings, sexual and physical abuse, and political unrest,” Moreau said. “Most people think of PTSD as affecting combat veterans, but it affects so many more people than that.”

Trauma and PTSD have a variety of causes, agreed Ryan Holliday, Ph.D., assistant professor in the Department of Psychiatry at CU and co-investigator on Moreau’s study. He noted people can experience sleep disruptions, including nightmares and prolonged insomnia, following trauma without necessarily having PTSD. However, he added, “In my clinical and research experience, sleep disruptions are almost always associated with PTSD.”

The consequences of those disruptions can be profound, Holliday added. For example, a person suffering from PTSD-related nightmares who is having trouble falling asleep may turn to alcohol for help.

“They may get into a pattern of thinking, ‘I can’t fall asleep unless I drink,’” Holliday said. “Then they have to drink more and more to fall asleep.”

Attempt to supplement existing care

The FDA stressed that NightWare is not a stand-alone therapy for PTSD. In fact, Holliday said, providers have well-established treatments for breaking sleepless cycles for people burdened by PTSD. These include anti-depressant and sleep medications and talk therapies, such as prolonged exposure and cognitive processing. Cognitive behavioral therapy can also help treat insomnia.

“I’m a big believer in these treatments,” Holliday said. “We know they work better than other treatments, and they help people get better relatively quickly.”

He added, however, that the therapies don’t work for some people, while others may not stick with them. The challenge is to also find “augments” to treatment that “will help to increase the number of people who benefit.”

NightWare may or may not be one of those PTSD treatment augments, Holliday said, but data about its effectiveness were “initially promising.” He also said the device benefits from being “relatively easy” to implement, with little disruption to patients’ lives. That increases the chances that they will use it regularly.

“If we can develop and design small things we can add to treatment, that could give us a bigger return on our investment,” Holliday said. Having more options, in turn, could help people prevent their PTSD from progressing before they seek help, he said.

“We want to catch it before symptoms become rampant and impact people in so many different domains,” Holliday said.

Could the cardiovascular and nervous systems be among those damaged domains? Moreau hopes to find out. She added that she plans to continue studying the “biologic pathways” that underlie cardiovascular disease and searching for clues that help the development of supplements, medications and other therapies. But the societal upheaval she sees on the rise provides a broader drive.

The release of a device like NightWare “was timely with the mental health woes we are suffering,” Moreau said. “At this point in my career, I just want to help people.”

Anyone (including non-veterans) interested in receiving more information about the NightWare trial can contact [email protected] or 303-724-1396.


About the author

Tyler Smith has been a health care writer, with a focus on hospitals, since 1996. He served as a writer and editor for the Marketing and Communications team at University of Colorado Hospital and UCHealth from 2007 to 2017. More recently, he has reported for and contributed stories to the University of Colorado School of Medicine, the Colorado School of Public Health and the Colorado Bioscience Association.