FDA approves Nightware app on Apple Watch to treat sleep disturbances

pharmafile | November 9, 2020 | News story | Sales and Marketing  

The FDA has authorised the marketing of Nightware, a digital therapeutic application for the Apple Watch, in treating sleep disturbances. 

The application is approved to treat nightmares in adults over the age of 22 who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD).

The therapeutic uses an Apple Watch or iPhone that are properly configured with the app, and throughout the night monitors body movements and heart rate during sleep. The data is sent to the app which creates a unique profile for the user. If the app detects the participant is experiencing a nightmare it will make the Apple Watch gently vibrate in an attempt to interrupt the user without waking them up.

The FDA recommends that this should not be used on a patient who is prone to sleepwalking or violence during a nightmare. The patient should also not wear the device when watching TV or doing other activities that could throw off the device. 

Carlos Peña, the Director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said: “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 authorisation offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares.”

This authorisation comes after the device was studied in a 30-day randomised sham-controlled trial of 70 patients. A sham therapy is an inactive treatment that mimics a possible therapy in a clinical trial. Both the sham and active groups showed improvement on the sleep scales, with the active group showing greater improvement than the sham. The evidence demonstrated the probable benefits outweighed the probable risks.

Conor Kavanagh

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