FDA approves Apple Watch app NightWare to treat PTSD nightmares

Posted:
in Apple Watch
The US Food and Drug Administration has approved an Apple Watch app to help with the treatment of PTSD, with NightWare being an app available only under a prescription.




The approval of the app enables NightWare to be marketed as an aid for the "temporary reduction of sleep disturbance related to nightmares in adults," the FDA declared on Friday, including those who suffer from nightmare disorder or have disturbed sleep from post-traumatic stress disorder.

The app uses the sensors on the Apple Watch to monitor body movements and heart rate during sleep, which are analyzed and used to create a sleep profile for the patient. If it is detected that the patient is experiencing a nightmare, by comparing movements and pulse against the sleep profile, the Apple Watch vibrates to disrupt the user's sleep and to bring them out of the nightmare.

Testing of the app determined it was successful in improving the quality of sleep for sufferers, with it outperforming a control group as part of the "sham-controlled trial."

While NightWare is an app, it isn't one that will be readily available to use by anyone. It is available by prescription only, is intended to be used alongside prescribed PTSD medications and other therapies, and under the supervision of a healthcare provider.

Furthermore, the FDA warns the app should not be used by patients who "act out" during nightmares by sleepwalking or being violent, nor to be used while reading or watching television to prevent false alerts.

The app was granted a "Breakthrough Device" designation for treating PTSD nightmares, a process that is designed to speed up the development and review of hardware and services that could offer effective treatment or diagnosis for life-threatening or "irreversibly debilitating diseases or conditions."

While it isn't directly consumer-usable, the app is certainly an extension to Apple's existing efforts to improve the sleeping habits of its customers. The Sleep Mode and sleep tracking in iOS 14 and watchOS 7 offers reports to users on how well they sleep, as well as encouraging healthy habits in winding down to sleep at appropriate times.
Jantonelli81

Comments

  • Reply 1 of 13
    Interesting. Glad to see that it's only part of a regimen to help folks. Can't fall into the trap that technology on its own is the panacea to cure ills. I would be interested to know how the App Store handles the "prescription only" aspect of this. Can anyone download, but only people who have provided prescription info to the company directly hav access to open it?
    JWSC
  • Reply 2 of 13
    peteopeteo Posts: 395member
    Fist ever FDA approved Nightmare on Elm street watch app!

    1,2 Freedy's coming for you
    edited November 2020
  • Reply 3 of 13
    This is utter BS to restrict an app to require a prescription?!  🤯
  • Reply 4 of 13
    This is utter BS to restrict an app to require a prescription?!  🤯
    Did you read the section describing how it's meant to be part of a supervised treatment program?

    "While NightWare is an app, it isn't one that will be readily available to use by anyone. It is available by prescription only, is intended to be used alongside prescribed PTSD medications and other therapies, and under the supervision of a healthcare provider. "

    Your long term memory is not working when you are dreaming and you only have about a 15 minute buffer in short term memory. That's why longer dreams get so weird. Also why you don't remember most dreams - they aren't stored UNLESS you wake up while they are still in short term memory.

    I have to wonder: does waking up the sufferer during a nightmare help them process things better, or be able to discuss more because they recall what they were dreaming?
    CloudTalkinmike1
  • Reply 5 of 13
    sflocalsflocal Posts: 5,728member
    peteo said:
    Fist ever FDA approved Nightmare on Elm street watch app!

    1,2 Freedy's coming for you
    I hope this doesn't result in Freddy being pulled out of the nightmare as well and wreaking havoc in the waking world.  I bet there's an army of lawyers waiting to file those future lawsuits.
  • Reply 6 of 13
    flydogflydog Posts: 1,005member
    This is utter BS to restrict an app to require a prescription?!  ߤ怜t;/div>
    Yeah maybe read the article before commenting:

    the FDA warns the app should not be used by patients who "act out" during nightmares by sleepwalking or being violent 
    Seems like the sort of thing a doctor should be supervising.  




    edited November 2020 CloudTalkinmike1
  • Reply 7 of 13
    mike1mike1 Posts: 2,738member

    Seems like a really good idea.

    edited November 2020
  • Reply 8 of 13
    mike1mike1 Posts: 2,738member
    This is utter BS to restrict an app to require a prescription?!  🤯


    CloudTalkin
  • Reply 9 of 13
    sflocalsflocal Posts: 5,728member
    This is utter BS to restrict an app to require a prescription?!  🤯
    Have you always been special that reading articles doesn't apply to you?
  • Reply 10 of 13
    MacProMacPro Posts: 19,379member
    sflocal said:
    This is utter BS to restrict an app to require a prescription?!  🤯
    Have you always been special that reading articles doesn't apply to you?
    He's just 'special'. ;)
  • Reply 11 of 13
    "The NightWare™ platform has been cleared by the FDA"
    Cleared by FDA is not the same as Approved by the FDA - the title of this article should be changed for legal reasons.
  • Reply 12 of 13
    I myself would love to give this a try. I was medically separated after 15 years of service after I was diagnosed with Type 1 Narcolepsy. One of the symptoms that some people with Narcolepsy suffer from are night terrors. I frequently have night terrors. Sometimes they wake me up. Sometimes Tim (the love of my life) will wake me up. After being woke I rarely remember what the dream was about. I know that if I close my eyes and fall right back to sleep the night terror returns. I actually have to get up and walk around, or talk with Tim, or get a glass of water before going back to sleep. While there is no way to prove just how I developed Narcolepsy, I was separated with a  “service connected” medical condition. I believe a very traumatic experience I had is what brought Narcolepsy to me. The times I remember my night terrors they are definitly related to that specific time period. Which to me qualifies as PTSD. 
    I plan on talking to my PCP at my next VA appointment. I would seriously like to give this app a try. 
    Congratulations to the young man that developed this app. I am sure you understand the potential life changes that proper treatment and this app can provide for people who suffer from night terrors. As every time you see or speak with your father you are reminded how you saved his life. Thank you...even if I am not able to use the app, thank you for developing it. 


  • Reply 13 of 13
    As a psychologist who treats veterans with PTSD I am intrigued by this. I would like to read the literature that shows the results with this app. I also treat nightmare disorder and realize that nightmares become an avoidance mechanism. I'm wondering if you have looked into that during the studies. Do you HAVE peer-reviewed studies? Thank you.
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