Table 2.
Sleep variables.
| Sleep Variables | Baseline (Mean ± SD) |
4 Weeks (Mean ± SD) |
12 Weeks (Mean ± SD) |
Time †
(p Value) |
Interaction * (p Value) |
|---|---|---|---|---|---|
| TST (min) | 0.154 | 0.089 | |||
| Placebo | 307.10 ± 39.90 | 296.35 ± 52.06 | 332.29 ± 29.57 | 0.078 | |
| Treatment | 320.46 ± 44.24 | 290.27 ± 35.60 | 293.08 ± 65.95 | 0.009 | |
| Stage N1 (%) | 0.102 | 0.567 | |||
| Placebo | 8.66 ± 4.49 | 11.06 ± 6.54 | 10.37 ± 8.66 | 0.687 | |
| Treatment | 9.27 ± 2.99 | 12.73 ± 5.24 | 14.31 ± 8.78 | 0.040 | |
| Stage N2 (%) | 0.069 | 0.487 | |||
| Placebo | 51.84 ± 6.45 | 48.85 ± 10.36 | 45.38 ± 8.48 | 0.008 | |
| Treatment | 51.21 ± 8.86 | 51.37 ± 7.59 | 49.09 ± 8.64 | 0.564 | |
| Stage N3 (%) | 0.694 | 0.286 | |||
| Placebo | 17.93 ± 5.38 | 21.89 ± 8.08 | 18.36 ± 8.97 | 0.375 | |
| Treatment | 19.51 ± 8.80 | 17.26 ± 10.29 | 17.45 ± 7.94 | 0.616 | |
| Stage REM (%) | 0.077 | 0.130 | |||
| Placebo | 21.57 ± 6.95 | 17.18 ± 9.19 | 25.89 ± 8.45 | 0.040 | |
| Treatment | 20.02 ± 7.61 | 18.63 ± 7.62 | 19.15 ± 9.60 | 0.860 | |
| Sleep efficiency (%) | 0.150 | 0.177 | |||
| Placebo | 81.46 ± 9.42 | 76.83 ± 11.06 | 87.43 ± 6.66 | 0.047 | |
| Treatment | 83.08 ± 9.27 | 78.17 ± 8.92 | 78.89 ± 17.58 | 0.080 | |
| Sleep latency (min) | 0.442 | 0.496 | |||
| Placebo | 21.63 ± 21.46 | 11.48 ± 7.65 | 12.65 ± 7.38 | 0.411 | |
| Treatment | 15.94 ± 15.46 | 16.58 ± 12.72 | 13.9 ± 25.85 | 0.908 | |
| Arousal index | 0.028 | 0.763 | |||
| Placebo | 29.80 ± 15.80 | 39.08 ± 16.28 | 30.37 ± 15.78 | 0.133 | |
| Treatment | 35.23 ± 13.02 | 43.71 ± 11.99 | 39.54 ± 16.83 | 0.008 | |
| AHI | 0.310 | 0.467 | |||
| Placebo | 1.60 ± 1.95 | 1.86 ± 2.44 | 1.63 ± 3.24 | 0.811 | |
| Treatment | 12.89 ± 21.24 | 14.78 ± 23.13 | 10.72 ± 17.01 | 0.310 | |
| PLM index | 0.809 | 0.251 | |||
| Placebo | 2.24 ± 3.82 | 1.31 ± 2.02 | 1.85 ± 4.24 | 0.749 | |
| Treatment | 0.42 ± 0.91 | 2.34 ± 4.86 | 1.42 ± 3.17 | 0.280 |
Abbreviations: TST, total sleep time; AHI, apnea–hypopnea index; PLM, periodic limb movement. Data are presented as mean ± standard deviation values and underwent log transformed for comparison. † Intragroup and * intergroup interactions were evaluated by repeated measures ANOVA.