New Apple Watch App Approved by FDA for PTSD Treatment

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The U.S. Food and Drug Administration (FDA) has recently permitted marketing activities of a novel device aimed at temporarily reducing sleep disturbance stemming from nightmares in ages 22 and up.

The device is for those who experience nightmare disorder or nightmares tied to post-traumatic stress disorder (PTSD). The device gives haptic feedback through a wristwatch—but does not wake the user—in response to heart rate and bodily motion patterns indicating nightmares.

Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices in FDA says “Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need. Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares."

What is PTSD?

PTSD is a pervasive disorder that is triggered in response to a dangerous, scary, or shocking event.

After living through trauma, people may experience a range of symptoms and most eventually recover from it in time. When it persists though, sleep problems and nightmares take hold, and the person may be diagnosed with PTSD.

There are certain medications that help with its symptoms and an experienced mental health professional can go a long way in addressing the individual needs and symptoms of patients.

The device is named NightWare, it works over an Apple Watch and an iPhone. Users log into an app and configure the software according to their preferences, and it's all stored in NightWare servers.

Throughout your sleep, Apple Watch's sensors monitor heart rate and body movements. The collected data is sent over to NighWare servers and a proprietary algorithm creates a unique sleep profile for the patient. When what the sensors read overlap with nightmare patterns, it provides vibrations through Apple Watch.

The product is only available by prescription and intended for home use.

How the device was studied

70 patients were gathered for a 30-day long, randomized, and sham-controlled trial. The sham subjects were given an ineffective mock treatment that's intended to mimic the actual treatment. In essence, the sham group wore the device and underwent all the other processes as the actual trial group, but they were given no vibrations during their sleep.

All the patients were assessed in several metrics such as suicidality and sleep depravity, neither metric got worse over the course of the study in both groups. What was decisive was that the improvement in sleep scales in both groups.

While both groups showed an improvement, the actual trial group saw more improvement. In conclusion, the study showed that the potential benefits outweighed the probable risks

How it will actually be implemented into real-world scenarios

While promising, simply strapping a watch in someone's wrist and calling it a day is not a viable option for a multifaceted malady like PTSD. So, the device should be used in tandem with prescription medication, and ideally, therapy according to consensus guidelines. And they also need to be monitored by a health professional meanwhile.

Patients who are known to sleepwalk or act violently during sleep should not use NightWare, and the relevant health professionals should be informed if daytime sleepiness emerges.

Also so as not to skew data, the device should now be worn or activated while reading or watching stuff in bed. The device may also disturb the bedpartner of the wearer if they have any. And additionally, due to the aforementioned reason, it also should not come into contact with bedpartners.

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