FDA grants clearance for NightWare app designed to reduce PTSD-related nightmares
FDA clears De Novo to prescribe Apple Watch app for nightmare disorder (MobiHealth News): On Friday, the FDA granted Minneapolis-based NightWare De Novo clearance for its Apple Watch and iPhone app designed to improve the quality of sleep for those with nightmarish disorders and PTSD-related nightmares. Digital therapy - which received the agency's breakthrough designation […]

FDA clears De Novo to prescribe Apple Watch app for nightmare disorder (MobiHealth News):

On Friday, the FDA granted Minneapolis-based NightWare De Novo clearance for its Apple Watch and iPhone app designed to improve the quality of sleep for those with nightmarish disorders and PTSD-related nightmares.

Digital therapy - which received the agency's breakthrough designation last year - uses the watch's sensors to track users' heart rate and movements while they sleep. After establishing a baseline profile for the patient in a night or two of sleep, the machine learning algorithm detects heart rate or movement abnormalities likely caused by a nightmare. The app then vibrates the smartwatch just enough to interrupt the wearer's dreams, but not enough to wake them up or disrupt their circadian sleep cycle.

Digital Therapeutics is intended for home use in adults 22 years of age or older and will require a prescription. The agency stressed in the announcement that this is not a stand-alone therapy for PTSD and should be used with other prescribed medications or recommended therapies.

The FDA announcement:

FDA clears new device designed to reduce nightmare-related sleep disturbances in some adults (Press release):

Today, the United States Food and Drug Administration cleared a new device for sale to temporarily reduce nightmarish sleep disturbances in adults 22 years of age or older who experience nightmares or nightmares due to post-traumatic stress disorder (PTSD). The device provides gentle vibrations through touch based on an analysis of heart rate and movements during sleep.

"Sleep is an integral part of a person's daily routine. However, some adults who suffer from a nightmare disorder or suffer from nightmares due to PTSD cannot get the rest they need. Today's clearance offers a new, low-risk treatment option that uses digital technology with the aim of temporarily alleviating sleep disturbances associated with nightmares, ”said Carlos Peña, Ph.D., Director of the Office neurological and physical medicine devices in the Center for Devices and Radiological Health of the FDA…

This device has been studied in a 30-day randomized controlled trial involving 70 patients. A sham therapy is an inactive treatment or procedure that aims to mimic therapy as closely as possible in a clinical trial. Patients in the sham group wore the device, but no vibratory stimulation was provided. Safety was assessed using validated measures of suicidality and sleepiness, and there was no change in either over the course of the study in either group. Sleep was assessed using two versions of the Pittsburgh Sleep Quality Index, the self-rated questionnaire for assessing sleep quality, including a version of this scale for patients with PTSD. The simulated and active groups showed improvement on the sleep scales, with the active group showing greater improvement than the simulated groups. Evidence has shown that the likely benefits outweigh the likely risks.

News in context:

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