IMPORTANT SAFETY INFORMATION

INTENDED USE/INDICATION FOR USE

The NightWare digital therapeutic is indicated to provide vibrotactile feedback on an Apple Watch based on an analysis of heart rate and motion during sleep for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). It is intended for home use.

CONTRAINDICATIONS

If you have acted out your nightmares (i.e. sleepwalking, violence) do not use NightWare and contact your Healthcare Provider.

WARNINGS
  • NightWare is not a standalone therapy for PTSD. The device should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, according to relevant consensus guidelines.
  • If daytime sleepiness occurs, contact your Healthcare Provider.
  • If you feel drowsy, do not drive or operate heavy machinery. Contact your health care provider.
  • If the watch vibration causes awakenings not associated with nightmares, please contact your Healthcare Provider.
  • If nightmares persist, worsen, or recur, contact your Healthcare Provider.
  • If skin irritation occurs, discontinue use of the watch and contact your Healthcare Provider.
  • Your watch may disturb your bedpartner. Try not to expose your bedpartner to the watch at night.
  • Do not wear the watch too tightly, it should feel comfortable and snug, not tight on your wrist.
  • Wear the watch only when you are planning to go to sleep; do not wear it while reading or watching TV in bed as this may trigger false alerts.
  • Use the NightWare watch every night.
  • Not intended for use by individuals under age 22.
  • The long term safety and effectiveness of the NightWare device has not been established.
  • The long term effects of the NightWare device use on the sleep architecture have not been established.
  • The long term effects of the NightWare device on the sleep architecture have not been established.
PRECAUTIONS
  • Do not drop or crush the smartphone or watch.
  • Be sure to charge the smartphone and watch every day.