U.S. Food and Drug Administration issued the following announcement on Nov. 6.
The U.S. Food and Drug Administration 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 touch based on an analysis of heart rate and motion during sleep.
“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. 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,” said Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.
PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. People may experience a range of reactions after trauma, and most will recover from their symptoms over time. Those who continue to experience symptoms, which can include sleep problems and nightmares, may be diagnosed with PTSD. Certain medications may help address specific PTSD symptoms, such as sleep problems and nightmares. An experienced mental health professional can help people find the treatment plan that meets their symptoms and needs.
The device, called 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 patient. When Nightware detects that a patient 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 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, according to relevant consensus guidelines. Nightware is intended to be used under the supervision of a healthcare provider. Patients who have been known to “act out” during their nightmares (sleepwalking, violence) should not use Nightware. A healthcare provider should be contacted if daytime sleepiness occurs (If you feel drowsy, do not drive or operate heavy machinery); if the watch vibration causes awakenings not associated with nightmares; or if nightmares persist, worsen, or recur. The watch included in the Nightware kit should be used every night when the user is planning to go to sleep. The watch should not be worn while reading or watching television in bed as this may trigger false alerts. Users should not wear the watch too tightly. If skin irritation occurs, users should discontinue the use of the watch and contact a healthcare provider. The watch included in the Nightware kit may disturb the sleep of the user’s bedpartner if the bedpartner is in contact with the watch when it vibrates. Patients are advised to avoid letting the watch come in contact with their bedpartner at night.
Nightware was granted Breakthrough Device designation for the treatment of nightmares in patients with PTSD. Breakthrough Device designation is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. The regulation created is for digital therapy device to reduce sleep disturbance for psychiatric conditions, prescription devices that are intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or PTSD.
The FDA granted the marketing authorization to Nightware, Inc.
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