The US Food and Drug Administration (FDA) approved a new device as a Breakthrough Device aimed at reducing sleep disturbance related to nightmares in adults with post-traumatic stress disorder (PTSD).
The prescription device, dubbed Nightware, works by providing a gentle vibration through touch based on an analysis of heart rate and motion during sleep.
The digital therapeutic devices uses an Apple Watch and an Apple iPhone configured and logged into a specific software application, as well as the Nightware server.
The Apple Watch will sense body movement and heart rate changes throughout the night and sends the data to the server. Using a proprietary algorithm, the device creates a unique sleep profile for each patient.
When the system detects a patient experiencing a nightmare it will provide vibrations through the Apple Watch.
The approval is based on a 30-day randomized, sham-controlled trial involving 70 patients.
Patients in the sham group worse the device with no vibratory stimulation provided. The investigators assessed safety using validated measurements of suicidality and sleepiness. Ultimately, there were no changes in either measure over the course of the study in either therapy group.
The investigators also assessed sleep with 2 versions of the Pittsburgh Sleep Quality Index scale, the self-rated questionnaire for assessing sleep quality, including a version of the scale intended for patients with PTSD.
Both groups showed improvement in the sleep scales, with the active group showing more improvement.
The device is not considered a standalone therapy and should be used in conjunction with prescribed medications and other recommended therapies.
“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,” Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”