Table 3.
Descriptive statistics of polysomnography at baseline and end of randomized treatment and regression analysis of polysomnography comparing treatment groups at end of randomized treatment
| PSG Continuous Measures | Time | Eszopiclone N=30 | Placebo N=30 | p value1,2 |
|---|---|---|---|---|
| Latency to 1st Epoch of Sleep (min) | Pre | 10.8 [24.5] | 17.3 [24.0] | |
| Post1 | 17.0 [14.5] | 17.0 [22.0] | 0.535 | |
| Latency to Persistent Sleep (min) | Pre | 20.5 [35.5] | 31.5 [27.0] | |
| Post1 | 20.0 [21.5] | 22.0 [23.5] | 0.471 | |
| Wakefulness after Sleep Onset (min) | Pre | 73.09 (8.8) | 44.47 (8.8) | |
| Post2 | 30.56 (5.5) | 59.18 (5.3) | 0.001 | |
| Total Sleep Time (min) | Pre | 388.5 [108.0] | 411.5 [61.0] | |
| Post1 | 426.5 [52.5] | 396.5 [65.5] | 0.007 | |
| Sleep Efficiency (%) | Pre | 80.8 [22.5] | 85.7 [12.8] | |
| Post1 | 88.9 [11.0] | 82.6 [13.6] | 0.006 | |
| REM Latency (min) | Pre | 83.7 (9.0) | 80.1 (8.9) | |
| Post2 | 154.4 (18.2) | 187.6 (17.6) | 0.186 | |
| Stage 1 Minutes | Pre | 32.4 (6.5) | 40.0 (6.4) | |
| Post2 | 50.1 (7.1) | 42.9 (7.0) | 0.464 | |
| Stage 1 Percent of Total Sleep Time | Pre | 6.6 [7.0] | 7.3 [10.2] | |
| Post1 | 8.6 [14.9] | 10.5 [9.0] | 0.807 | |
| Stage 2 Minutes | Pre | 32.4 (6.5) | 40.0 (6.4) | |
| Post2 | 50.1 (7.1) | 42.9 (7.0) | 0.464 | |
| Stage 2 Percent of Total Sleep Time | Pre | 52.1 (2.6) | 50.6 (2.5) | |
| Post2 | 55.1 (3.4) | 54.3 (3.3) | 0.866 | |
| Slow Wave Sleep Minutes | Pre | 69.1 (5.9) | 62.7 (5.9) | |
| Post2 | 61.2 (6.8) | 63.3 (6.6) | 0.818 | |
| Slow Wave Sleep Percent of Total Sleep Time | Pre | 18.0 (1.5) | 15.6 (1.5) | |
| Post2 | 14.4 (1.6) | 16.6 (1.6) | 0.327 | |
| REM Minutes | Pre | 71.2 (6.5) | 87.9 (6.4) | |
| Post2 | 69.0 (7.2) | 59.8 (7.1) | 0.358 | |
| REM Percent of Total Sleep Time | Pre | 18.7 (1.5) | 21.7 (1.5) | |
| Post2 | 16.3 (1.7) | 15.0 (1.6) | 0.561 | |
| PSG Dichotomized Measures | Time & Cut Point | Eszopiclone N (%) | Placebo N (%) | p value3 |
| PLM Index (rate #/hr) | Pre 0–5 | 23 (76.7) | 23 (76.7) | |
| Pre > 5 | 7 (23.3) | 7 (23.3) | ||
| Post 0–5 | 11 (47.8) | 11 (47.8) | 0.663 | |
| Post > 5 | 12 (52.2) | 12 (52.2) | ||
| PLM Arousal Index (rate #/hr) | Pre 0–5 | 26 (86.7) | 27 (90.0) | |
| Pre > 5 | 4 (13.3) | 3 (10.0) | ||
| Post 0–5 | 18 (78.3) | 17 (73.9) | 0.807 | |
| Post > 5 | 5 (21.7) | 6 (26.1) | ||
| Apnea/hypopnea index (rate #/hr) | Pre 0–5 | 26 (86.7) | 27 (90.0) | |
| Pre > 5 | 4 (13.3) | 3 (10.0) | ||
| Post 0–5 | 19 (82.6) | 18 (78.3) | 0.790 | |
| Post > 5 | 4 (17.4) | 5 (21.7) | ||
| Number of desaturations (count) | Pre 0–5 | 26 (86.7) | 30 (100) | |
| Pre > 5 | 4 (13.3) | 0 (0) | ||
| Post 0–5 | 20 (87.0) | 18 (78.3) | 0.171 | |
| Post > 5 | 3 (13.0) | 5 (21.7) | ||
| Lowest saturation (%) | Pre 0–90 | 27 (90.0) | 26 (86.7) | |
| Pre > 90 | 3 (10.0) | 4 (13.3) | ||
| Post 0–90 | 21 (91.3) | 22 (95.7) | 0.267 | |
| Post > 90 | 2 (8.7) | 1 (4.3) | ||
| Number of Spontaneous Arousals (count) | Pre 0–50 | 18 (60.0) | 15 (50.0) | |
| Pre > 50 | 12 (40.0) | 15 (50.0) | ||
| Post 0–50 | 6 (26.1) | 10 (43.5) | 0.384 | |
| Post > 50 | 17 (72.9) | 13 (56.5) | ||
| Spontaneous Arousal Index (rate #/hr) | Pre 0–10 | 20 (66.7) | 19 (63.3) | |
| Pre > 10 | 10 (33.3) | 11 (36.7) | ||
| Post 0–10 | 8 (34.8) | 11 (47.8) | 0.713 | |
| Post > 10 | 15 (65.2) | 12 (52.2) |
Pre and post medians and Interquartile ranges are presented. p-values from Generalized Linear Models on the rank of the post value compare treatment groups and adjust for baseline, age and gender.
Pre and post least square means and standard errors are presented. p-values from Generalized Linear Models of the post value compare treatment groups and adjust for baseline, age and gender.
Categorized pre and post values are presented. p-values from Logistic Regression Models of the binary post data compare treatment groups and adjust for baseline, age and gender.
Numbers in ( ) = percent; numbers in [ ] = SD.