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FDA Approves Apple Watch App Designed to Stop Nightmares

NightWare gently vibrates users out of bad dreams so they can have a more restful sleep.

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The US Food and Drug Administration (FDA) on Friday gave the green light to a new iOS app designed to reduce "sleep disturbance" in adults who suffer from a nightmare disorder or PTSD.

Dubbed NightWare, the digital therapy uses an Apple Watch and connected iPhone to monitor body movement and heart rate during sleep. When a nightmare is detected (based on motion and pulse), the watch gently vibrates, pulling the user out of their bad dream without awakening them.

Sleep is an essential part of anyone's daily routine, but certain folks are robbed of their forty winks by factors out of their control—until now. Available by prescription only, NightWare collects individuals' data and, using a proprietary algorithm, creates a unique sleep profile for each patient.

"[This] 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," according to Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health.

The device was studied in a 30-day randomized trial of 70 patients, using a self-rated questionnaire for assessing sleep quality. The results, according to the FDA, "demonstrated the probable benefits outweighed the probable risks."

NightWare is not a standalone therapy for post-traumatic stress disorder, and should be used in conjunction with prescribed medications and other professional therapies. People who have been known to "act out" during nightmares (i.e. sleepwalking, violence) should not use this device. Inquire online to see if you quality for a NightWare study.

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Stephanie Mlot

Stephanie Mlot

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