Description of Event or Problem · 0
PRODUCT: NIGHTWARE HTTPS://NIGHTWARE.COM/ MEDICAL FINDING: ELEVATION IN BLOOD PRESSURE; USE OF NIGHTWARE INCREASES BLOOD PRESSURE; MANUFACTURER DOES NOT DISCLOSE THIS ON THEIR WEBSITE OR TO PHYSICIANS. HOWEVER, ON MY REVIEW, THIS FINDING WAS REPORTED TO THE FDA FOR INITIAL CLEARANCE. NIGHTWARE MARKETS ITSELF AS HAVING EFFICACY - EFFICACY RESULTS HTTPS://NIGHTWARE.COM/PROFESSIONALS/ THE FOLLOWING IS FROM THE MANUFACTURERS WEBSITE ACCESSED (B)(6) 2023 "GIVEN THAT THIS MEASURE SPECIFICALLY INDEXES SLEEP DISTURBANCES ASSOCIATED WITH PTSD, THE STRENGTH OF THIS DISSOCIATION PROVIDES EVIDENCE THAT TRAUMA-RELATED NIGHTMARES ARE EFFECTIVELY TARGETED BY THE NIGHTWARE DEVICE. NIGHTWARE ON THEIR WEBSITE REPORTS "EFFICACY OVER PLACEBO". NIGHTWARE DEMONSTRATED EFFICACY OVER PLACEBO DURING CLINICAL TRIALS. IT EXHIBITED A 3.2-POINT IMPROVEMENT ON THE PITTSBURGH SLEEP QUALITY IMPROVEMENT SCALE IN AN ONGOING RANDOMIZED CONTROLLED TRIAL. THIS EXCEEDS THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE. THE PSQI-A IMPROVEMENT WAS MORE THAN DOUBLE THAT OF THE SHAM DEVICE. ADDITIONALLY, NIGHTWARE STATES THE FOLLOWING: "BEFORE THE FDA CLEARS ANY DEVICE OR DRUG FOR MARKETING TO THE PUBLIC, THE MANUFACTURER MUST DEMONSTRATE TO THE AGENCY'S SATISFACTION THAT THE PRODUCT IS EFFECTIVE AND SAFE." THESE STATEMENTS ARE LISTED ON THE WEBPAGE HTTPS://NIGHTWARE.COM/PATIENT-FAQ/ PLEASE NOTE THE FDA HTTPS://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF20/DEN200033.PDF DOES NOT ESTABLISH THAT NIGHTWARE IS EFFECTIVE.