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);…