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Apple Watch App That May Help Relieve PTSD Patients Gets US FDA Approval

NightWare app for Apple Watch

NightWare app for Apple Watch

The NightWare app for Apple Watch uses sensors on the device to monitor heart rate and body movements to produce mild vibrations that may help to address the PTSD-related nightmares without waking the patient up.

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Abhik Sengupta

The Apple Watch is adding a new app that will address nightmare-related sleep issues faced by patients with post-traumatic stress disorder (PTSD). The Apple Watch app, NightWare recently received approval from the US Food and Drug Administration (FDA) and can only be used with a prescription under the supervision of a healthcare provider. The FDA; however, notes that the NightWare app is not a standalone therapy for patients with PTSD, and it should be used in conjunction with prescribed medications and other recommended treatments for PTSD-associated nightmares.

To address PTSD-related nightmares, the NightWare app uses gyroscope and accelerometer sensors on the Apple Watch to monitor body movements and heart rate during sleep. The app then sends the data to its servers, and via a proprietary algorithm, it creates a unique sleep profile for the patient. In case, the patient is suffering from a PTSD-related nightmare during sleep - the Apple Watch produces vibrations to interrupt bad dreams without waking the patient up.

The US FDA says that the NightWare app for the Apple Watch was tested on 70 patients during a sham-controlled trial. 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' sleep cycles during the trial were assessed through the Pittsburgh Sleep Quality Index scale and personal questionnaires. "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 reported stated.

The FDA cautions that PTSD patients using NightWare app, should not wear Apple Watch while reading or watching television as it may trigger false alerts. Users should not wear the Apple smartwatch too tightly as it may also cause skin irritation over time. Additionally, the US health agency adds that patients who have been known to "act out" during their nightmares (sleepwalking, violence) should not use the NightWare app. The app is also given the Breakthrough Device designation by the FDA that is typically reserved for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. In any case, patients who face PTSD-related nightmares despite the NightWare app via Apple Watch, are advised to contact their doctors or healthcare supervisors.

Patients with the proper prescription can sign up for the app via NightWare website. Patients suffering from PTSD in India who want to use the NightWare app via Apple Watch might require approval from the CDSCO (India Central Drugs Standard Control Organisation) and the pertinent healthcare official.


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