Table 5.
Adverse Events
Adverse event | Forehead sleep system (N = 54) N (%) |
Vestibular sleep system (N = 52) N (%) |
---|---|---|
Headache | 3 (5.6%) | 0 (0.0%) |
Strep throat | 0 (0.0%) | 1 (1.9%) |
Right knee contusion | 1 (1.9%) | 0 (0.0%) |
Leg cramp | 1 (1.9%) | 0 (0.0%) |
Pain at site of electrodes | 0 (0.0%) | 1 (1.9%) |
Total AEs | 5 (9.3%) | 2 (3.8%) |
Total − related AEs | 3 (5.6%) | 1 (1.9%) |
Total AEs refer to all adverse events observed in the trial irrespective of whether they were thought related to the device (active or sham). Related AEs refer to adverse events deemed possibly or probably related to the device (active or sham).