Table 6.
Sleep Diary parameters in the 65-80 age group.
| Treatment effects | |||||
|---|---|---|---|---|---|
| Change from baseline Mean (SD) |
Short term | Long term * | |||
| Visit 3 | Visit 7 | Estimate (95% CI) P-value |
Estimate (95% CI) P-value |
||
| NMAX | PRM | 137 | 159 | ||
| Placebo | 144 | 61 | |||
| Sleep latency | PRM | -19.1 (47.3) | -25.9 (46.4) | -15.6 (-25.3, -6.0) | -14.5 (-21.4, -7.7) |
| (min) | Placebo | -1.7 (47.8) | -8.3 (61.5) | P = 0.002 | P < 0.001 |
| Sleep | PRM | -0.24 (0.80) | -0.31 (0.94) | -0.17 (-0.33, 0.00) | -0.09 (-0.22, 0.03) |
| maintenance | Placebo | -0.09 (0.78) | -0.20 (0.70) | P = 0.046 | P = 0.148 |
| Total sleep | PRM | 0.34 (0.75) | 0.64 (0.99) | 7.0 (-3.4, 17.4) | 7.5 (-0.7, 15.7) |
| time (h) | Placebo | 0.20 (0.79) | 0.41 (1.06) | P = 0.186 | P = 0.073 |
| Sleep onset | PRM | -0.22 (0.80) | -0.41 (0.75) | -0.22 (-0.39, -0.05) | -0.21 (-0.33, -0.08) |
| (hours) | Placebo | 0.00 (0.71) | -0.12 (1.06) | P = 0.012 | P = 0.002 |
| Sleep offset | PRM | 0.03 (0.81) | 0.03 (0.84) | -0.16 (-0.33, 0.02) | -0.12 (-0.24, 0.00) |
| (h) | Placebo | 0.19 (0.79) | 0.21 (0.91) | P = 0.076 | P = 0.051 |
| Refreshed on | PRM | -0.10 (0.36) | -0.22 (0.42) | 0.00 (-0.08, 0.08) | -0.06 (-0.12, 0.00) |
| waking | Placebo | -0.09 (0.37) | -0.11 (0.42) | P = 0.994 | P = 0.053 |
| Morning | PRM | -0.18 (0.52) | -0.36 (0.69) | -0.04 (-0.16, 0.07) | -0.10 (-0.19, -0.01) |
| alertness | Placebo | -0.11 (0.51) | -0.09 (0.60) | P = 0.453 | P = 0.032 |
| PRM | -0.20 (0.56) | -0.39 (0.71) | -0.06 (-0.19, 0.07) | -0.08 (-0.18, 0.01) | |
| Sleep quality | Placebo | -0.12 (0.57) | -0.17 (0.54) | P = 0.356 | P = 0.082 |
Mean (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)
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) sleep latency (diary data) are repeated for completeness.
CI, confidence interval