Table 5.
Assessment of PSQI scores
| Evaluation | Mean ± SD | P value (vs. baseline) | P value (vs. placebo) | 95% CI vs. Baseline | 95% CI vs. Placebo | P value, change from baseline (vs. placebo) | |
|---|---|---|---|---|---|---|---|
| Subjective sleep quality | |||||||
| Placebo | Baseline | 1.66 ± 0.86 | - | - | - | - | - |
| Day 42 | 1.85 ± 0.94 | 0.1805 | - | -0.14, 0.52 | - | - | |
| Day 84 | 1.51 ± 0.97 | 0.4089 | - | -0.18, 0.48 | - | - | |
| LN18178 | Baseline | 1.42 ± 0.80 | 0.1237 | - | -0.07, 0.55 | - | |
| Day 42 | 1.25 ± 0.79 | 0.2050 | 0.0015 | -0.13, 0.47 | 0.28, 0.92 | 0.0693 | |
| Day 84 | 0.72 ± 0.67 | < 0.0001 | < 0.0001 | 0.43, 0.97 | 0.48, 1.10 | 0.0160 | |
| Sleep latency | |||||||
| Placebo | Baseline | 2.22 ± 0.59 | - | - | - | - | - |
| Day 42 | 1.97 ± 0.56 | 0.0115 | - | 0.04, 0.46 | - | - | |
| Day 84 | 1.71 ± 0.53 | < 0.000 | - | 0.31, 0.71 | - | - | |
| LN18178 | Baseline | 2.18 ± 0.47 | 0.6510 | - | -0.16, 0.24 | - | |
| Day 42 | 1.96 ± 0.42 | 0.0075 | 0.8964 | 0.05, 0.39 | -0.17, 0.19 | 0.5119 | |
| Day 84 | 1.53 ± 0.50 | < 0.0001 | 0.0763 | 0.47, 0.83 | -0.01, 0.37 | 0.2870 | |
| Sleep duration | |||||||
| Placebo | Baseline | 0.83 ± 0.85 | - | - | - | - | |
| Day 42 | 0.56 ± 0.68 | 0.0389 | - | -0.01, 0.55 | - | - | |
| Day 84 | 0.47 ± 0.63 | 0.0026 | - | 0.09, 0.63 | - | - | |
| LN18178 | Baseline | 0.47 ± 0.68 | 0.0147 | - | 0.08, 0.64 | - | |
| Day 42 | 0.46 ± 0.71 | 0.8821 | 0.5223 | -0.25, 0.27 | -0.16, 0.36 | 0.1141 | |
| Day 84 | 0.35 ± 0.64 | 0.3930 | 0.2960 | -0.13, 0.37 | -0.11, 0.35 | 0.1663 | |
| Habitual sleep efficiency | |||||||
| Placebo | Baseline | 0.15 ± 0.36 | - | - | - | - | - |
| Day 42 | 0.10 ± 0.30 | 0.5488 | - | -0.07, 0.17 | - | - | |
| Day 84 | 0.07 ± 0.25 | 0.2266 | - | -0.03, 0.19 | - | - | |
| LN18178 | Baseline | 0.12 ± 0.38 | 0.6676 | - | -0.11, 0.17 | - | |
| Day 42 | 0.09 ± 0.29 | 0.7266 | 0.9276 | -0.10, 0.16 | -0.10, 0.12 | 0.8268 | |
| Day 84 | 0.19 ± 0.48 | 0.4978 | 0.1131 | -0.09, 0.23 | -0.02, 0.26 | 0.1092 | |
| Sleep disturbances | |||||||
| Placebo | Baseline | 2.03 ± 0.26 | - | - | - | - | - |
| Day 42 | 1.62 ± 0.49 | < 0.0001 | - | 0.27, 0.55 | - | - | |
| Day 84 | 1.63 ± 0.49 | < 0.0001 | - | 0.26, 0.54 | - | - | |
| LN18178 | Baseline | 2.00 ± 0.27 | 0.4904 | - | -0.07, 0.13 | - | |
| Day 42 | 1.77 ± 0.42 | 0.001 | 0.0849 | 0.10, 0.36 | -0.02, 0.32 | 0.0683 | |
| Day 84 | 1.28 ± 0.45 | <0.0001 | 0.0002 | 0.58, 0.86 | 0.18, 0.52 | 0.0019 | |
| Use of sleep medication | |||||||
| Placebo | Baseline | 0.00 ± 0.00 | - | - | - | - | - |
| Day 42 | 0.00 ± 0.00 | - | - | 0, 0 | - | - | |
| Day 84 | 0.00 ± 0.00 | - | - | 0, 0 | - | - | |
| LN18178 | Baseline | 0.00 ± 0.00 | - | - | - | - | - |
| Day 42 | 0.00 ± 0.00 | - | - | 0, 0 | - | - | |
| Day 84 | 0.00 ± 0.00 | - | - | 0, 0 | - | - | |
| Daytime dysfunction | |||||||
| Placebo | Baseline | 1.46 ± 0.68 | - | - | - | - | - |
| Day 42 | 1.68 ± 0.68 | 0.0039 | - | -0.03, 0.47 | - | - | |
| Day 84 | 1.51 ±0.73 | 0.6592 | - | -0.21, 0.31 | - | - | |
| LN18178 | Baseline | 1.70 ± 0.65 | 0.0509 | - | -0.004, 0.48 | - | |
| Day 42 | 1.12 ± 0.66 | < 0.0001 | < 0.0001 | 0.34, 0.82 | 0.31, 0.81 | < 0.0001 | |
| Day 84 | 1.05 ± 0.79 | < 0.0001 | 0.0070 | 0.38, 0.92 | 0.18, 0.74 | 0.0003 | |
| Global PSQI score | |||||||
| Placebo | Baseline | 8.36 ± 1.81 | - | - | - | - | - |
| Day 42 | 7.78 ± 1.89 | 0.0096 | - | -0.09, 1.25 | - | - | |
| Day 84 | 6.90 ± 1.60 | < 0.0001 | - | 0.84, 2.08 | - | - | |
| LN18178 | Baseline | 7.89 ± 1.71 | 0.1609 | - | -0.18, 1.12 | - | |
| Day 42 | 6.65 ± 1.60 | < 0.0001 | 0.0009 | 0.63, 1.85 | 0.48, 1.78 | 0.0346 | |
| Day 84 | 5.12 ± 1.69 | < 0.0001 | < 0.0001 | 2.14, 3.40 | 1.17, 2.39 | 0.0006 | |
Values present mean ± SD. placebo (n=59) and LN18178 (n=57). CI: Confidence interval; P < 0.05 was considered as statistically significant for 'within the group' and 'between the groups' comparison analysis using paired t-test and ANCOVA, respectively, as described in materials and methods.