The US Food and Drug Administration (FDA) has allowed marketing a new device that can temporarily reduce sleep disturbance caused by nightmares in people who are 22 or above. The device is effective on those adults who are suffering from nightmare disorder or have trouble sleeping due to post-traumatic stress disorder (PTSD).
The new device is known as "Nightware" and it can be bought if someone has the prescription for home use. As per the federal agency, this device provides gentle vibration to help a person's heart rate and movements during sleep. FDA has granted the marketing authorization to Nightware, Inc.
A Breakthrough Device
This new device was previously granted "Breakthrough Device" designation for the treatment of nightmares in PTSD patients by FDA, under the 'Breakthrough Devices Program'—which according to the agency is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of critical or irreversibly debilitating diseases or health conditions.
Nightmares or a disturbing dream associated with negative feelings, is common in children but it can happen at any age. However, the frequency of such dreams and related nightmare distress is linked to sleep disturbance, as well as, waking psychopathology.
The product 'Nightware' is a digital therapeutic. It uses an iPhone and Apple Watch that are configured and logged into a software application, as well as the server of the medical device. During sleep, the Apple watch sensors carefully monitor the body motions and heart rate. All the collected data then sent to the Nightware server.
The device then creates a unique sleep profile for the patients by using a proprietary algorithm. When Nightware identifies that a person is experiencing a nightmare based on the analysis, it creates a vibration through the Apple Watch.
In terms of PTSD, a person can develop such a condition after encountering a shocking, scary, or dangerous incident. While many recover from their symptoms over time, some individuals continue to experience the symptoms, and eventually that could cause sleep disturbance and nightmares.
As per the US federal agency, Nightware was studied in a 30-day randomized, sham-controlled trial, involving 70 patients. People who were in the sham group wore the Nightware, but no vibratory stimulation was provided. "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," said FDA.
Participants in sham and active groups showed improvement on the sleep scales. But people involved in the active group showed greater improvement than sham group. However, as per the federal agency, the evidence demonstrated the probable benefits exceeded the probable risks.
The Usage of Nightware
FDA said that the device is not a standalone therapy for PTSD and it should be used "in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, according to relevant consensus guidelines". It is important that those who have been known to "act out" during their nightmares—having a history of sleepwalking—should not use the device.
In a statement, FDA also noted that the watch included in the Nightware kit should not be used while reading or watching television in bed as this may trigger false alerts and that the users should avoid wearing the watch too tight.