Last Observation Carried Forward (LOCF) | SD | LOCF p* | VLD CBP vs Placebo | ||||||
---|---|---|---|---|---|---|---|---|---|
Treatment | Baseline (SD) | Week 8 (SD) | Mean Change | % of Baseline | Treatment p** | % of Baseline | |||
Total time awake, h | VLD CBP | 1.3 (0.9) | 0.8 (0.5) | –0.5 | –38.5 | 0.74 | 0.011† | 0.100 | 0.0 |
Placebo | 0.9 (0.7) | 0.8 (0.5) | –0.1 | –11.1 | 0.50 | 0.408 | |||
Total sleep time, h | VLD CBP | 5.7 (1.2) | 6.4 (1.1) | 0.7 | 12.3 | 0.93 | 0.005† | 0.156 | 0.0 |
Placebo | 0.9 (0.7) | 0.8 (0.5) | –0.1 | –11.1 | 0.50 | 0.408 | |||
Stage 1, % | VLD CBP | 10.3 (3.7) | 11.5 (3.8) | 1.2 | 11.7 | 3.72 | 0.189 | 0.205 | 16.6 |
Placebo | 10.2 (5.0) | 9.8 (4.6) | –0.4 | –3.9 | 3.86 | 0.666 | |||
Stage 2, % | VLD CBP | 52.9 (8.1) | 56.5 (10.0) | 3.5 | 6.8 | 9.04 | 0.119 | 0.021† | 11.1 |
Placebo | 53.2 (6.7) | 50.6 (6.8) | –2.6 | –4.9 | 5.87 | 0.077 | |||
Stage 3, % | VLD CBP | 7.4 (3.3) | 8.6 (4.3) | 1.2 | 16.2 | 3.52 | 0.166 | 0.166 | 21.9 |
Placebo | 7.2 (2.2) | 7 (1.9) | –0.2 | –2.8 | 2.04 | 0.683 | |||
Stage 4, % | VLD CBP | 10.5 (7.8) | 7.5 (8.0) | –3.0 | –28.6 | 7.64 | 0.114 | 0.029† | –55.1 |
Placebo | 10.9 (5.5) | 13.4 (5.5) | 2.5 | 22.9 | 6.81 | 0.138 | |||
REM, % | VLD CBP | 18.8 (5.2) | 15.9 (5.1) | –2.9 | –15.4 | 4.18 | 0.764 | 0.007† | –17.3 |
Placebo | 18.1 (5.1) | 19.1 (4.1) | 1.0 | 5.5 | 4.29 | 0.337 | |||
Sleep efficiency, % | VLD CBP | 73.6 (20.9) | 85.1 (11.2) | 11.5 | 15.6 | 19.56 | 0.023† | 0.099 | –2.3 |
Placebo | 83.9 (13.4) | 86.9 (8.7) | 3.0 | 3.6 | 8.31 | 0.144 |