The US Food and Drug Administration (FDA) approved the smartwatch NightWare as a therapeutic device for nightmare disorder linked to post-traumatic stress disorder (PTSD). The person's function during the day is affected by these repetitive and extremely dysphoric dreams that lead to anxiety.
"Sleep is an essential part of a person's daily routine," said Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health director Carlos Peña, Ph.D.. He added the FDA's authorization offers a low-risk treatment option using digital technology for providing "temporary relief from sleep disturbance related to nightmares."
FDA Grants Vibrating Smartwatch as “breakthrough device” for speedy review as nightmare disorder and PTSD therapy for military, war veterans
NightWare Vibrating Smartwatch is a 'breakthrough device'
According to Wired, the FDA named the vibrating smartwatch as a "breakthrough device," so it may go through faster approving process for treatments of debilitating and life-threatening disorder. As PTSD has been associated with rising cases of suicide, it has already been included among these illnesses, which can cause symptoms that are hard to cure.
In 2021, the NightWare watch will be available for free by prescription using the US Department of Defense and Veterans Administration health plans of veterans or the military.
Nightware app uses Apple Watch sensors to check heart rate and body movements during sleep. These are then analyzed and used to develop the patient's sleep profile. The app will then compare pulse and movements , which could detect if the patient experiences nightmare. The watch would vibrate to disrupt the user's sleep and to bring them out of the nightmare.
NightWare Vibrating Smartwatch is a “breakthrough device”
According to FDA's authorization announcement, it should be noted that NightWare should not be used to replace existing PTSD medications and therapy or be used solely as a "stand-alone therapy."
"Nightmare disorder tends to be one of the most invasive parts of PTSD, because you can't escape it," Nightware CEO Grady Hannah said.
Based on the FDA application, NightWare submitted an unpublished data from 70 veterans who are part of an ongoing study, which is being done in partnership with Minneapolis VA Medical Center. The study will have a total of 240 veterans throughout the process. It also showed that the Nightware device improved the sleep quality of volunteers.
NightWare Vibrating Smartwatch is a “breakthrough device”
Researchers continue to gather data from NightWare while the device will soon send data to a cloud-based data repository to allow doctors to track a person's sleep metrics. Meanwhile, the Center for Medicare and Medicaid Services considers adding Medicare for devices that have FDA breakthrough status, which would soon open up a new market aside from military and veteran users.
How to treat PSTD and nightmares
While each individual has occasional nightmare, particularly those involving being chased or falling. Those regular nightmares and dreams happen during REM sleep.
About 4% of Americans experience distressing and recurring nightmares, which disrupts sleep and impairs daily functioning. The Nightmare disorder usually occurs after a traumatic experience.
Meanwhile, volunteers who have recurring nightmares may have the individuals either asleep or wide awake. These traumatic memories are stuck in the short-term or narrative while memory and do not fade like others.
Nowadays, getting stuck in a traumatic experience such as COVID-19 brings lingering fatigue and terror. Extreme events like the Hurricane Katrina or 9/11 terrorist attacks invade the dreams and disrupt the sleep of those living with trauma.
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Written by CJ Robles
