Table 3.
Simulated night shift assessments
| Measure | Placebo Mean ± SD | Ramelteon Mean ± SD | Effect Size | p value |
|---|---|---|---|---|
| PVT median RT (sec) | 0.362 ± 0.25 | 0.662 ± 0.16 | 0.22 | 0.0193** |
| PVT lapses | 13.2 ± 16 | 15.5 ± 16.3 | 0.14 | 0.0001** |
| VAS alert (delta) | 12.0 ± 12.7 | 16.9 ± 13.7 | 0.37 | 0.0143*** |
| ADD correct | 42.9 ± 15.7 | 42.6 ± 13.8 | 0.7104 | |
| DSST correct | 54.4 ± 11.6 | 52.3 ± 10.6 | 0.19 | 0.0341*** |
| KSS (delta) | 1.1 ± 1.2 | 1.5 ± 1.2 | 0.33 | 0.0091*** |
| Flanker (msec) | 29.6 ± 114 | 46.8 ± 97.3 | 0.2995 | |
| PRM - free recall | 4.2 ± 1.8 | 4 ± 1.8 | 0.2707 | |
| PRM - recognition | 5.6 ± 0.87 | 5.3 ± 1.0 | 0.32 | 0.0432*** |
| KDT - TLFA | 1.7 ± 1.6 | 1.8 ± 1.7 | 0.5050 |
Primary endpoints correctedα:** = p < 0.025;
Secondary endpoints uncorrectedα*** = p < 0.05
PVT, Psychomotor Vigilance Task; RT, reaction time; VAS, visual analog scale alertness; ADD, addition task; DSST, digit symbol substitution task; KSS, Karolinska Sleepiness Scale; PRM, Probe Recall Memory; KDT, Karolinska Drowsiness Test; TLFA, theta low frequency alpha (5.5-9 Hz) power