Device uses an Apple Watch to deliver gentle vibrations to users suffering from post-traumatic stress disorder.
The FDA has granted marketing approval for a device meant to help reduce sleep disturbances related to nightmares in adults aged 22 years or older who suffer from nightmare disorder or have nightmares related to post-traumatic stress disorder (PTSD).
PTSD is a disorder that some people develop after experiencing a scarring, shocking, or dangerous event. After trauma, people may experience a range of reactions but many will recover from their symptoms over time. Those who continue to experience symptoms, which may include nightmares, may be diagnosed with PTSD.
The device, known as Nightware, delivers a gentle vibration through touch based on an analysis of heart rate and motion during sleep. Nightware uses an Apple Watch and an Apple iPhone that are configured and logged into a software application and Nightware server.
Sensors on the Apple Watch monitor body movement and heart rate during sleep with the data being sent back to Nightware Server. A proprietary algorithm creates a unique sleep profile for the patient and the watch delivers a gentle vibration when the algorithm determines the patient is having a nightmare.
Approval was based on a 30-day randomized, sham-controlled trial of 70 patients. A sham therapy is an inactive treatment or procedure meant to mimic as closely as possible to the actual therapy in a clinical trial. During the trial, the control group wore the device, but no vibratory simulation was provided.
Safety was assessed using validated measurements of suicidality and sleepiness. Both the sham and active group showed improvements on the sleep scale, but the active group showed a greater improvement.
“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,” said Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a press release.
Nightware is not a standalone therapy for PTSD and should be used in conjunction with other therapies, according to the FDA. Patients who are known to sleepwalk or otherwise “act out” during nightmares should not use the device.
FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults [News Release] November 6, 2020; White Oak, MD. Accessed November 10, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-device-designed-reduce-sleep-disturbance-related-nightmares-certain-adults?utm_medium=email&utm_source=govdelivery.