Health
The new device aims to reduce nightmares in PTSD patients
PTSD is a disorder that develops after experiencing scarring, shock, or dangerous events. After trauma, people may experience a variety of reactions, but many recover from their symptoms over time. People who continue to experience symptoms that may include nightmares may be diagnosed with PTSD.
Called nightwear, this device provides gentle vibrations with touch, based on an analysis of heart rate and movement during sleep. Nightware uses an Apple Watch and Apple iPhone that are configured and logged in to software applications and Nightware servers.
Apple Watch sensors monitor your body movements and heart rate during sleep, and the data is sent back to the Nightware Server. The watch provides a gentle vibration when a unique algorithm creates a patient-specific sleep profile and the algorithm determines that the patient has a nightmare.
Approval is based on a 30-day randomized controlled trial of 70 patients. Pseudotherapy is an inactive treatment or procedure that aims to mimic the actual therapy in a clinical trial as closely as possible. During the study, the control group wore the device, but no vibration simulation was provided.
Safety was assessed using validated measurements of suicidal tendencies and drowsiness. Both the fake group and the active group showed improved sleep scale, while the active group showed greater improvement.
“Sleep is an integral part of a person’s daily life. However, certain adults with nightmare disorders or experiencing nightmares due to PTSD cannot get the rest they need. Today’s authorization is It offers a new low-risk treatment option that uses digital technology to provide temporary relief from nightmare-related sleep disorders, “said Dr. Carlos Peña, director of the FDA’s Center for Neurophysical Medicine. Stated. For press release devices and radiation health.
According to the FDA, nightwear should be used in combination with other therapies, not monotherapy for PTSD. Patients who fall asleep in a nightmare or are known to otherwise “act” should not use the device.
reference:
The FDA allows marketing of new devices designed to reduce sleep disorders associated with certain adult nightmares [News Release] November 6, 2020; White Oak, Maryland. Accessed on November 10, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-device-designed-reduce-sleep-disturbance-related-nightmares-certain-adults?utm_medium=email&utm_source=govdelivery..
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