FDA authorizes marketing of new device intended to provide temporary relief from sleep disturbances

fda authorizes marketing of new device intended to provide temporary relief from sleep disturbances

Sumary of FDA authorizes marketing of new device intended to provide temporary relief from sleep disturbances:

  • Food and Drug Administration permitted marketing of a new device intended 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)..
  • Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares.”.
  • Those who continue to experience symptoms, which can include sleep problems and nightmares, may be diagnosed with PTSD..
  • These data are sent to the Nightware server and, using a proprietary algorithm, the device creates a unique sleep profile for the patient..
  • A sham therapy is an inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial..
  • Safety was assessed using validated measurements of suicidality and sleepiness, and there were no changes in either over the course of the study in either group..
  • Sleep was assessed with two versions of the Pittsburgh Sleep Quality Index scale, the self-rated questionnaire for assessing sleep quality, including a version of that scale that is intended for patients with PTSD..
  • Both the sham and active groups showed improvement on the sleep scales, with the active group showing greater improvement than sham..
  • A healthcare provider should be contacted if daytime sleepiness occurs (If you feel drowsy, do not drive or operate heavy machinery);…

Want to know more click here go to health news source.

From -

Close

Languages