• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FDA OKs Canon Medical's One-Beat Spectral Cardiac CT

    NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite

    IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System

    Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

    Iterative Scopes Announces IBD-Focused Scientific Advisory Board
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Home Is Where the Heart (Valve) Is

    CGM: Digital Health Meets a Very Large Opportunity

    Biomechanical Engineer, Heal Thyself

    Optimizing MIM in Medical Device Manufacturing

    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Qosina Corp.

    Spectrum Plastics Group

    Creganna Medical, part of TE Connectivity

    maxon

    Trademark Plastics Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

    EMS Providers Valued for Product Customization, Medical Certification Expertise

    Three Future Trends and Opportunities in Quality Assurance

    Adopting a Data-Driven Quality Model

    Digital Transformation for Quality and Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    FUTEK Advanced Sensor Technology Inc.

    K-Tube Technologies

    PTI Engineered Plastics Inc.

    Unicep

    maxon
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    A Breakthrough for the Nightmarish Effects of PTSD

    ...

    A Breakthrough for the Nightmarish Effects of PTSD
    Related CONTENT
    • BRAINBox's Traumatic Brain Injury Test Wins Breakthrough Status
    • 6 Trends Reshaping Medical Equipment Manufacturing
    • FDA Authorizes First Test to Detect Zika Antibodies
    • FDA Offers Update on Efforts to Ensure Breast Implant Safety
    • FDA Approves Device to Help Increase Access to More Lungs for Transplant
    Sam Brusco, Associate Editor06.13.19
    Though I am not a particularly strong supporter of Apple—and you’re welcome to contact me to find out why—I have to admit the Apple Watch could be a useful tool for proactive health monitoring.

    The Apple Watch Series 4, released last year, came equipped with an electrocardiogram (ECG) sensor and app to capture the heart’s rhythm. The company did its homework and also obtained clearance from the U.S. Food and Drug Administration (FDA) for the ECG tool around the time of release. Health Canada also issued active licenses for the ECG and irregular heart rhythm notification features on May 16.

    Further affirming the feature’s utility, Stanford University School of Medicine shared the early results of a 400,000-participant study during the last week of April to determine if the mobile app could accurately identify atrial fibrillation (AFib). Stanford researchers reported the wearable technology can safely identify heart rate irregularities, which subsequent testing confirmed to be AFib.

    This clearance has opened the door for other health-conscious smartwatch applications running on the Apple Watch Platform. They don’t necessarily have to be directly cardiac related, either. For example, on May 21, NightWare Inc., a Minneapolis-based startup that develops digital therapeutics for mental health, received FDA Breakthrough Status for its NightWare product, which measures and treats nightmares for sufferers of post-traumatic stress disorder (PTSD).

    Among the many other disconcerting symptoms of PTSD, it is estimated that almost 5 million Americans suffer from Nightmare Disorder related to PTSD. Nightmares and Nightmare Disorder have long been associated with a slew of worrisome effects—increased suicidality, heightened heart disease risk and diabetes, and cognitive difficulties like memory loss, anxiety, and depression. A single nightmare event is enough to make anyone anxious or upset, but repeated nightmares and interrupted sleep can bring PTSD sufferers’ trauma to the forefront nearly every night.

    For those unfamiliar with what a Breakthrough Designation means, it occurs when the FDA recognizes a therapeutic solution for a life-threatening condition for which no currently approved treatment is able to offer similar benefits to the proposed therapy. This designation allows the FDA to grant priority review when preliminary clinical trials indicate a given therapy might offer substantial advantages over existing options for patients with serious or life-threatening diseases. A breakthrough therapy designation is requested by the company providing the solution. In some cases, the FDA may suggest the sponsor consider submitting a breakthrough request if, after reviewing the submitted data, the agency thinks the program might meet breakthrough criteria and the development program will benefit from the designation.

    “This is truly a watershed moment for our company,” NightWare CEO and founder Grady Hannah told the press. “In our initial studies, NightWare has demonstrated substantial and significant efficacy. The FDA’s Breakthrough Status designation will enable us to complete our Randomized Clinical Trials ahead of schedule and give us the opportunity to help improve the lives of veterans and others suffering from PTSD sooner than we anticipated. Our team is humbled and excited by this FDA designation.”

    The NightWare application operates by tracking, intervening, and processing nightmare events. As the wearer slumbers, the app continuously analyzes heart rate, accelerometer, and gyroscope data collected from the Apple Watch’s integrated sensors to learn sleep patterns in the first few days of wearing the watch each night. The “learning period” usually takes less than 10 days to apply machine learning algorithms for a profile of the individual’s sleep patterns. A “stress threshold” is computed during this time based on spikes in heart rate and movement, indicating a nightmare event has begun.

    Once the learning period is over, whenever the application detects a potential nightmare it intervenes by vibrating (also called vibrotactile feedback). The watch will vibrate enough to arouse the sleeper out of sleep without waking them. The intended result is the nightmare is interrupted by the sudden arousal without interrupting the sleeper’s circadian sleep pattern, allowing for high quality, more restful sleep.

    The app begins with low-intensity vibration. But if it detects the nightmare event has not been halted, the app increases the intervention intensity. The watch app also sends the collected data to a secure cloud service to facilitate review by a healthcare professional. NightWare also comes equipped with a desktop app to display stress, intervention, and other collected data. Tech-savvy individuals can use the desktop app to review their data, or a healthcare professional could use it to review data for multiple users.

    “We’ve seen a markedly large effect size for improved sleep quality in NightWare open label trials,” NightWare Chief Medical Officer Daniel Karlin, M.D. commented to the press. “We are excited to get folks enrolled in these randomized trials to further verify the observed efficacy.”

    NightWare is early in development and currently not available for sale. The company is currently enrolling patients in two randomized clinical trials (RCT), one of which is being conducted at VA hospitals in Minneapolis and St. Cloud, Minn. The company is also enrolling in a virtual RCT trial broader in geographic scope. If interested, prospective participants can get more information about enrollment at http://bit.ly/2W1it51. 
    Related Searches
    • nightmares
    • quality
    • stanford
    • healthcare
    Related Knowledge Center
    • Neurological
    • Digital Health
    Suggested For You
    BRAINBox BRAINBox's Traumatic Brain Injury Test Wins Breakthrough Status
    6 Trends Reshaping Medical Equipment Manufacturing 6 Trends Reshaping Medical Equipment Manufacturing
    FDA Authorizes First Test to Detect Zika Antibodies FDA Authorizes First Test to Detect Zika Antibodies
    FDA Offers Update on Efforts to Ensure Breast Implant Safety FDA Offers Update on Efforts to Ensure Breast Implant Safety
    FDA Approves Device to Help Increase Access to More Lungs for Transplant FDA Approves Device to Help Increase Access to More Lungs for Transplant
    Apple Heart Study Demonstrates Ability of Wearable Technology to Detect Atrial Fibrillation Apple Heart Study Demonstrates Ability of Wearable Technology to Detect Atrial Fibrillation
    Orchestra BioMed Orchestra BioMed's Virtue Sirolimus-Eluting Balloon Wins Breakthrough Status
    FDA Takes Steps to Reduce Surgical Stapler Risks FDA Takes Steps to Reduce Surgical Stapler Risks
    FDA Halts Sale of Pelvic Mesh in U.S. FDA Halts Sale of Pelvic Mesh in U.S.
    FDA Warns Genomics Lab About Illegally Marketing Genetic Test FDA Warns Genomics Lab About Illegally Marketing Genetic Test
    A New, Tailored Review Framework for Artificial Intelligence-Based Devices A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    Cardiac Care on the Can Cardiac Care on the Can
    Study: Apple Watch May Help Flag Heart Rhythm Problems Study: Apple Watch May Help Flag Heart Rhythm Problems
    It’s Time to Embrace Customer Centricity It’s Time to Embrace Customer Centricity
    Sum and Substance: Material Considerations for Changing Design Needs Sum and Substance: Material Considerations for Changing Design Needs

    Related Columns

    • Chronic Disease | Digital Health | Patient Monitoring
      CGM: Digital Health Meets a Very Large Opportunity

      CGM: Digital Health Meets a Very Large Opportunity

      Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.
      Maria Shepherd, President and Founder, Medi-Vantage 04.01.21

    • Digital Health
      How Digital Health Fits into the Medtech Mold

      How Digital Health Fits into the Medtech Mold

      Healthcare will need to adopt digital technologies that streamline and enhance connectivity.
      Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.01.21

    • Digital Health
      Five Themes to Watch as Digital Health Takes Center Stage

      Five Themes to Watch as Digital Health Takes Center Stage

      Here are five themes to watch in the sector, including what life sciences developers and investors should know about the current deal-making landscape.
      Stephen W. Bernstein, Partner, McDermott Will & Emery 03.03.21


    • Digital Health
      Digital Health Delivers During a Year for the Ages

      Digital Health Delivers During a Year for the Ages

      Internet of Medical Things technologies have emerged as the key enabler of a much more holistic and complete disease-state management toolbox.
      Brad Womble, Senior Director of Strategy, Marketing, and Mergers & Acquisitions, Jabil Healthcare 11.04.20

    • Digital Health
      What’s Apple Been Up To in Healthcare?

      What’s Apple Been Up To in Healthcare?

      Apple is building its bench with teams of physicians and engineers creating software and hardware to address the healthcare market.
      Maria Shepherd, President and Founder, Medi-Vantage 07.21.20

    • Digital Health
      The Rise of Digital Medical Devices and Implications for the Supply Chain

      The Rise of Digital Medical Devices and Implications for the Supply Chain

      ...
      Tony Freeman, President, A.S. Freeman Advisors LLC 07.21.20


    • Digital Health
      Hospital Advances in Digital Health Medical Technology

      Hospital Advances in Digital Health Medical Technology

      It's been stated, “What the world would have taken five years to achieve was accomplished in five weeks,” regarding virtual care and the U.S. population.
      Maria Shepherd, President and Founder, Medi-Vantage 06.04.20

    • Digital Health
      To Build or To Buy? In Data Analytics, That Is the Question

      To Build or To Buy? In Data Analytics, That Is the Question

      As companies undertake new types of analytics projects that require new skills beyond simple sales reporting, it’s worth revisiting the “build vs. buy” question
      Maria Kliatchko, Principal, ZS 03.04.20

    • Neurological
      Sing Me a Memory: A Digital Music Therapeutic for Dementia

      Sing Me a Memory: A Digital Music Therapeutic for Dementia

      Musical Health Technologies develops products based on growing scientific evidence that music can be a potent tool to treat Alzheimer’s and dementia.
      Sam Brusco, Associate Editor 01.29.20


    • Digital Health
      The Next Medtech Frontier: Digital Health and Home Healthcare

      The Next Medtech Frontier: Digital Health and Home Healthcare

      U.S. health systems want to find ways to reduce costs; however, the shift to treating patients at home instead of admitting them to a hospital is new.
      Maria Shepherd, President and Founder, Medi-Vantage 01.29.20

    • Digital Health | R&D & Design
      Speed Up or Risk Stepping Down: The New Reality of the Connected Healthcare Development Cycle

      Speed Up or Risk Stepping Down: The New Reality of the Connected Healthcare Development Cycle

      Digital health and connected devices are an extraordinary new tool for delivering on improving patient outcomes.
      Joe McBeth, VP Global Supply Chain, Jabil Healthcare 01.29.20

    • Digital Health
      An Update on Digital Health

      An Update on Digital Health

      ...
      Maria Shepherd, President and Founder, Medi-Vantage 11.04.19


    • Contract Manufacturing | Digital Health | Software & IT
      Connecting the Dots in Medical Device Outsourcing

      Connecting the Dots in Medical Device Outsourcing

      ...
      MPO Staff 07.30.19

    • Digital Health
      AI in Healthcare: Where Are We Now?

      AI in Healthcare: Where Are We Now?

      ...
      Maria Shepherd, President and Founder, Medi-Vantage 06.13.19

    • Cardiovascular | Diagnostics | Digital Health | Patient Monitoring
      Cardiac Care on the Can

      Cardiac Care on the Can

      ...
      Sam Brusco, Associate Editor 04.03.19


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Survey: Remote Patient Monitoring To Match Or Surpass In-Patient Within Five Years
    • Harnessing Critical Health Data With Wearable Technology
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Device Designed To Permanently Replace Failing Human Hearts
    Breaking News
    • FDA OKs Canon Medical's One-Beat Spectral Cardiac CT
    • NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite
    • IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System
    • Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development
    • Iterative Scopes Announces IBD-Focused Scientific Advisory Board
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Transporting Treatment: An Examination of Tubing Technologies
    • Face to (Virtual) Face: Telemedicine Now and Post-Pandemic
    • Outward Appearance: Reviewing Surface Treatment Options
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Review Concludes Refined Grains Have a Place in Healthy Eating Patterns
    AstaReal Astaxanthin Ingredient Receives U.S. Patent Approval
    Study on Kemin’s DailyZz Botanical Blend Uncovers Sleep Quality, Next-Day Performance Benefits
    Coatings World

    Latest Breaking News From Coatings World

    SOS '21 Call For Papers
    ICP Acquiring Choice Adhesives
    PPG Brand Olympic Stains Announces 1st Ever 2021 Stain Color of the Year
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs Canon Medical's One-Beat Spectral Cardiac CT
    NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite
    IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Resilience Acquires Ology Bioservices
    RDIF, Hualan Ink COVID-19 Vaccine Deal
    Kintor, Visum Enter COVID-19 Manufacturing Partnership
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    2021 Perfumed Plume Awards Announces Finalists
    Bésame Cosmetics Unveils Marilyn Monroe Collection
    Procos Opens U.S. Office
    Happi

    Latest Breaking News From Happi

    Hair Luxury Company Expands Availability of Its Vegan Beauty to Walmart Online
    ACI Appoints Director, State Government Affairs
    Jergens Launches Mother’s Day Campaign
    Ink World

    Latest Breaking News From Ink World

    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    SE-DA Invests in Kornit Presto S
    Acrylic Resins Market Worth $21.9 Billion by 2025: MarketsandMarkets
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Sakata INX and INX International continue sustainability efforts
    TLMI reveals Eugene Singer Award winners at Virtual Spring Summit
    Monadnock Paper Mills joins SGP
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Andritz to Supply Elliptical Cylinder Pre-Needler in France
    Ahlstrom-Munksjö to be Delisted from Nasdaq Stockholm
    Radienz Living Introduces Sustainable Products
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    AgNovos Healthcare's AGN1 LOEP SV Kit Obtains IDE
    First Surgeries Completed with Globus Medical's CREO ONE Robotic Screw
    BioMagnetic Sciences Names President and CEO
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    SEMI, Center for Automotive Research Collaborate
    Zebra Technologies Introduces New Alliance Track for PartnerConnect Channel Program
    Virtual ASMC 2021 Spotlights Advanced Semiconductor Manufacturing Excellence

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login