[author: Daniel Meckley]

Photo by Angus Gray on Unsplash

Today’s wearable devices — the ones that monitor the number of steps we take, our heart rate, and our sleep habits (to mention only a few) — walk the line between personal accessories and true medical devices. To clarify the differences the FDA has issued several guidance documents including “General Wellness: Policy for Low Risk Devices” and “Policy for Device Software Functions and Mobile Medical Applications.”

Just recently, the FDA granted permission to market Nightware, a new device intended to treat sleep disturbance related to nightmares in adults with post-traumatic stress disorder or other nightmare disorders.

Nightware is a digital therapeutic device that uses an Apple Watch and an iPhone configured and logged into a software application along with the Nightware server. The Apple Watch sensors monitor body movement and heart rate during sleep, and these data are sent to the Nightware server which use a proprietary algorithm to create a unique sleep profile for the patient. Once a sleep profile is established, the system tracks heart rate and body movement to detect when a user is experiencing a nightmare. When Nightware detects a nightmare, it triggers mild vibrations through the Apple Watch designed to disrupt the nightmare without waking the patient. Nightware also allows doctors and other healthcare providers to monitor the patient’s nightmare symptoms.

As with other therapeutic devices, Nightware has undergone a clinical trial to demonstrate its safety and effectiveness. Nightware intends to recruit additional test subjects by the end of 2021 to enhance its clinical trial. As the device is being marketed as a therapy for a medically diagnosed condition it will only be available with a prescription from a healthcare provider. The FDA makes clear Nightware is not a standalone therapy, but instead should only be used as part of a broader treatment protocol involving either medications or psychotherapy.

Digital therapeutics devices are being developed for an astounding range of conditions and may ultimately transform treatment by allowing healthcare providers to securely collect real-time data from patients and analyze that information to develop personalized treatment plans. Nightware now adds an additional promising component to the overall treatment of adults suffering from nightmare disorders.

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