Table 4.
Assessment | Baseline mean score ± SD | Final assessment LS mean score ± SE | Placebo-adjusted LS mean change from baseline with pregabalina | ||||
---|---|---|---|---|---|---|---|
Placebo | Pregabalin | Placebo | Pregabalin | Change | 95% CI | P-value | |
Sleep disturbanceb | 47.7 ± 26.1 | 48.0 ± 26.5 | 39.76 ± 1.31 | 30.27 ± 1.31 | -9.48 | -13.12, -5.85 | <0.0001* |
Sleep adequacy | 29.0 ± 23.7 | 28.7 ± 24.5 | 36.91 ± 1.41 | 44.39 ± 1.40 | 7.48 | 3.58, 11.38 | <0.0001* |
Quantity of sleep | 5.4 ± 1.4 | 5.6 ± 1.3 | 5.70 ± 0.06 | 5.99 ± 0.06 | 0.29 | 0.11, 0.47 | 0.0007* |
Awakening short of breath/headache | 25.8 ± 26.6 | 26.2 ± 26.1 | 22.99 ± 1.36 | 18.00 ± 1.36 | -4.99 | -8.77, -1.21 | 0.0049* |
Snoring | 26.5 ± 28.7 | 25.0 ± 28.1 | 24.19 ± 1.33 | 29.17 ± 1.33 | 4.98 | 1.29, 8.68 | 0.9958 |
Somnolence | 41.6 ± 23.3 | 40.5 ± 24.3 | 36.41 ± 1.29 | 47.71 ± 1.28 | 11.31 | 7.74, 14.87 | 1.0000 |
Overall sleep problems index | 49.8 ± 17.2 | 49.7 ± 18.5 | 42.66 ± 0.96 | 39.67 ± 0.95 | -2.99 | -5.65, -0.33 | 0.0137* |
aDifference in mean change from baseline, compared with placebo using the baseline score as covariate. bMOS-Sleep Scale subscales scored from 0 to 100 with higher scores indicating more of the attribute named in the subscale except for 'quantity of sleep', scored from 0 to 24 indicating the number of hours of sleep.
*Indicates statistical significance at the P <0.025 level.
CI, confidence interval; LS, least squares; MOS, Medical Outcomes Study; SD, standard deviation; SE, standard error