The U.S. Food and Drug Administration (FDA) granted marketing authorization of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). Nightware is a digital therapeutic that uses an Apple Watch and an Apple iPhone. Throughout the night, Apple Watch sensors monitor heart rate and body movement during sleep. When Nightware detects that a patient is experiencing a nightmare based on this information, the device provides vibrations through the Apple Watch while the product is in use. NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.
This device was studied in a 30-day randomized, sham-controlled trial of 70 patients. A sham therapy is an inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial. Patients in the sham group wore the device, but no vibratory stimulation was provided. Safety was assessed using validated measurements of suicidality and sleepiness, and there were no changes in either over the course of the study in either group. Sleep was assessed with two versions of the Pittsburgh Sleep Quality Index scale, the self-rated questionnaire for assessing sleep quality, including a version of that scale that is intended for patients with PTSD. Both the sham and active groups showed improvement on the sleep scales, with the active group showing greater improvement than sham. The evidence demonstrated the probable benefits outweighed the probable risks. Nightware is not a standalone therapy for PTSD. The device should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder.
>> FDA Press Release