The Food and Drug Administration has cleared for marketing a smartphone app that can detect and interrupt nightmares in adults with(PTSD).
The NightWare app, from Minneapolis-based NightWare Inc., runs on the Apple Watch and Apple iPhone.
During sleep, Apple Watch sensors monitor heart rate and body movement. These data are used to create a unique sleep profile using a proprietary algorithm.
When the NightWare app detects that a patient is experiencing a nightmare based on changes in heart rate and movement, it provides slight vibrations through the Apple Watch to arouse the patient and interrupt the nightmare, without fully awakening the patient, the company.
NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.
“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, Office of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health at the FDA, said in.
This authorization “offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief fromrelated to nightmares,” said Dr. Peña.
NightWare was tested in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibrations were provided.
Both the sham and active groups showed improvement in sleep on standard sleep scales, with the active group showing greater improvement than sham. “The evidence demonstrated the probable benefits outweighed the probable risks,” the FDA said in a statement.
and other recommended therapies for PTSD-associated nightmares and nightmare disorder, the agency said.
NightWare was granted breakthrough device designation for the treatment of nightmares in patients with PTSD. The device reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.
Along with this marketing authorization, the FDA is establishing “special controls” designed to provide a “reasonable assurance of safety and effectiveness for tests of this type,” the agency said.
A version of this article originally appeared on.