Table 7.
Pittsburgh Sleep Quality Index (PSQI) measures, Clinical Global Impression of Improvement (CGI-I) and World Health Organization-5 Index in the 65-80 age group.
| Change from baseline Mean (SD) |
Treatment effects | ||||
|---|---|---|---|---|---|
| Short term | Long term * | ||||
| Visit 3 | Visit 7 |
Estimate (95% CI) P-value |
Estimate (95% CI) P-value |
||
| NMAX | PRM | 136 | 164 | ||
| Placebo | 144 | 62 | |||
| PSQI | PRM | -1.86 (2.93) | -3.34 (3.37) | -0.64 (-1.25, -0.02) | -0.70 (-1.17, -0.23) |
| Global score | Placebo | -1.19 (2.53) | -2.08 (2.92) | P = 0.042 | P = 0.003 |
| PSQI | PRM | -0.32 (0.71) | -0.59 (0.82) | -0.09 (-0.23, 0.05) | -0.15 (-0.25, -0.04) |
| Component 1 | Placebo | -0.19 (0.65) | -0.34 (0.85) | P = 0.217 | P = 0.006 |
| PSQI | PRM | -0.43 (0.87) | -0.75 (0.99) | -0.23 (-0.41, -0.04) | -0.24 (-0.38, -0.10) |
| Component 2 | Placebo | -0.22 (0.74) | -0.52 (0.95) | P = 0.018 | P = 0.001 |
| PSQI | PRM | -0.48 (0.89) | -0.86 (1.08) | -0.10 (-0.29, 0.10) | -0.10 (-0.25, 0.05) |
| Component 3 | Placebo | -0.40 (0.89) | -0.65 (0.96) | P = 0.328 | P = 0.177 |
| PSQI | PRM | -0.32 (0.96) | -0.79 (1.22) | -0.05 (-0.27, 0.17) | -0.10 (-0.26, 0.06) |
| Component 4 | Placebo | -0.29 (1.04) | -0.47 (1.05) | P = 0.638 | P = 0.236 |
| PSQI | PRM | 0.01 (0.41) | -0.04 (0.43) | -0.05 (-0.13, 0.02) | 0.00 (-0.05, 0.05) |
| Component 5 | Placebo | 0.03 (0.39) | -0.02 (0.42) | P = 0.162 | P = 0.973 |
| PSQI | PRM | -0.01 (0.12) | 0.01 (0.18) | † | † |
| Component 6 | Placebo | 0.00 (0.00) | 0.00 (0.00) | ||
| PSQI | PRM | -0.30 (0.95) | -0.31 (0.94) | -0.04 (-0.19, 0.11) | -0.07 (-0.17, 0.02) |
| Component 7 | Placebo | -0.12 (0.69) | -0.10 (0.86) | P = 0.636 | P = 0.137 |
| PSQI | PRM | -25.4 (50.9) | -32.7 (49.3) | -13.7 (-23.5, -3.9) | -12.1 (-19.1, -5.1) |
| Question 2 | Placebo | -8.9 (48.0) | -19.0 (65.8) | P = 0.006 | P = 0.001 |
| PSQI | PRM | 0.58 (1.03) | 1.05 (1.29) | 0.10 (-0.13, 0.33) | 0.14 (-0.04, 0.32) |
| Question 4 | Placebo | 0.48 (1.00) | 0.71 (1.08) | P = 0.381 | P = 0.120 |
| PRM | 3.34 (1.17) | 2.70 (1.17) | -0.12 (-0.37, 0.14) | -0.20 (-0.38, -0.02) | |
| CGI-I‡ | Placebo | 3.54 (0.85) | 3.19 (1.11) | P = 0.364 | P = 0.027 |
| WHO-5 | PRM | 1.02 (3.73) | 1.51 (4.05) | 0.42 (-0.34, 1.18), | 0.55 (-0.02, 1.13) |
| Index | Placebo | 0.27 (3.15) | 0.35 (4.21) | P = 0.281 | P = 0.058 |
Mean (standard deviation; SD) changes from baseline at Visits 3 and 7, with estimates of short-term treatment effect (linear regression model, adjusted for baseline value and age) and long-term treatment effect (mixed effects regression model, adjusted for baseline value, age and visit; global treatment effect reported)
*Global treatment effect is estimated using a mixed-effect model for repeated measures and takes into account the treatment effect difference over the 26-weeks (at Visits 3, 4, 5, 6 and 7).
†Regression models for PSQI Component 6 not fitted due to lack of variability in the data.
‡ Data shown are for values recorded at each visit, and regression models do not include baseline adjustment, since CGI-I at baseline not defined.