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:


BrainHQ is your online headquarters for working out your brain. Think of it as a personal gym, where you exercise your memory, attention, brain speed, people skills, intelligence and navigation instead of your abs, delts, and quads. Just as our bodies require care and exercise over the course of life, so do our brains—especially as we age. BrainHQ provides the exercise your brain needs to be at its sharpest.

The BrainHQ brain-training program represents the culmination of 30 years of research in neurological science and related medicine. It was designed by an international team of neuroscientists, led by Michael Merzenich—a professor emeritus in neurophysiology, member of the National Academy of Sciences, co-inventor of the cochlear implant, and Kavli Prize laureate.

Changing your brain takes some work—so while the BrainHQ exercises are sometimes fun, they can also be difficult. But they always give a useful, meaningful workout to your unique brain. Using a special algorithm, each exercise adapts in difficulty as you work so that you always train at the optimum level for you—where you are most likely to improve your performance.

It takes less than five minutes to do each BrainHQ level, so you can use it in tiny biroutes or long blocks, depending on your schedule. Plus you can use BrainHQ on almost any computer or mobile device, so you can take it on the go. If you want, you can set up personal training goals and have BrainHQ send you training reminders when you want them.

BrainHQ has 29 online exercises that work out attention, brain speed, memory, people skills, navigation, and intelligence. If you want, you can have BrainHQ tell you exactly which exercises to do, and in which order : the personalized se progager feature, designed by scientists, continually measures your performance and serves up the exercises that are right for you.. Or if you prefer, you can design your own program, choosing exercises and workouts that meet your personal interests, mood, and schedule.

More than 100 published scientific papers show the benefits of BrainHQ exercises and assessments. Most of these were independently conducted by scientists at respected universities, such as the University of California, Stanford, and Johns Hopkins. Of course, every study is conducted on a different group of people, and individual results vary. Click any benefit below to learn more about the studies behind the benefit.

From staplers to shelves to software, Demco supplies libraries with what they need to run. In 2015, they added BrainHQ to that mix. Through Demco, libraries can purchase BrainHQ to offer to their cardholders. People “check out” BrainHQ for free, like they would a book. Right now, it’s available in many public and military libraries across the U. S. —with more on the way.

Brain sport has basic principles : variety and curiosity. When anything you do becomes deuxième nature, you need to make a change. If you can do the crossword puzzle in your sleep, it’s time for you to move on to a new challenge in order to get the best workout for your brain. Curiosity about the world around you, how it works and how you can understand it will keep your brain sérieux fast and efficiently. Use the ideas below to help attain your quest for esprit fitness.

Brain fitness programs and games are a wonderful way to tease and challenge your brain. Suduko, crosswords and electronic games can all improve your brain’s speed and memory. These games rely on logic, word skills, math and more. These games are also fun. 1

You’ll get benefit more by doing these games a little bit every day. Spend 15 minutes or so, not hours.

Daily meditation is perhaps the solo greatest thing you can do for your mind/body health. Meditation not only relaxes you, it gives your brain a workout. By creating a different esprit state, you engage your brain in new and interesting ways while increasing your brain sport.

Your brain needs you to eat healthy fats. Focus on fish oils from wild salmon, nuts such as walnuts, seeds such as flax seed and olive oil. Eat more of these foods and less saturated fats. Eliminate transfats completely from your diet.

Stories are a way that we solidify memories, interpret events and share moments. Practice telling your stories, both new and old, so that they are interesting, compelling and fun. Some basic storytelling techniques will go a long way in keeping people’s interest both in you and in what you have to say.

SHOP NOW

Leave a Reply

Your email address will not be published. Required fields are marked *