The U.S. Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The device provides gentle vibration through a wrist-wearable device, based on an analysis of heart rate and motion during sleep.
The device, called NightWare, is an FDA-compliant medical device using a proprietary application on an Apple Watch that helps people suffering from traumatic nightmares get a more restful night’s sleep. It is a wearable technology that learns sleep patterns and customizes a treatment for each individual, interrupting nightmares so wearers can get an uninterrupted night’s sleep. The company was founded in 2015.
Nightware is a digital therapeutic that uses an Apple Watch and an Apple iPhone that are configured and logged into a software application and the Nightware server. Throughout the night, Apple Watch sensors monitor body movement and heart rate during sleep. These data are sent to the Nightware server and, using a proprietary algorithm, the device creates a unique sleep profile for the individual. When Nightware detects that a person is experiencing a nightmare based on its analysis of heart rate and body movement, the device provides vibrations through the Apple Watch while the product is in use. Nightware is available by prescription only and is intended for home use.
This device was studied in a 30-day randomized, sham-controlled trial of 70 people. A sham therapy is an inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial. People 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 people 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
This was reported by the U.S. Food and Drug Administration on November 6, 2020.
Contact information: NightWare, James Avenue South, Minneapolis, Minnesota 55419; 415-378-3789; Website: https://night-ware.com/
U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993; 301-348-1956; Website: https://www.fda.gov/