Table 2.
Baseline Characteristics of Patients in the Elderly Study
|
Placebo (N = 175) |
Gaboxadol 5 mg (N = 153) |
Gaboxadol 10 mg (N = 157) |
|
|---|---|---|---|
| Demographics | |||
| Mean (SD) age, y | 71.4 (5.2) | 70.6 (4.9) | 71.0 (5.2) |
| Mean (SD) body mass index, kg/m2 | 26.0 (3.6) | 26.7 (3.4) | 26.8 (3.6) |
| Female, % | 64.6 | 60.8 | 58.0 |
| White, % | 86.9 | 82.4 | 83.4 |
| PSG sleep measures, mean (SD)1 | |||
| WASO, min | 123.2 (35.7) | 118.7 (40.1) | 124.6 (37.4) |
| LPS, min | 52.4 (31.1) | 61.8 (38.7) | 56.4 (29.8) |
| TST, min | 313.1 (43.0) | 308.6 (51.4) | 308.4 (44.9) |
| NAW, n | 16.9 (6.3) | 16.6 (6.2) | 17.5 (7.4) |
| SWS, min | 41.2 (29.1) | 39.2 (29.9) | 36.7 (28.0) |
| Sleep architecture, mean (SD) min in each stage1 | |||
| Stage 1 | 40.4 (21.7) | 41.6 (21.6) | 41.1 (20.7) |
| Stage 2 | 172.1 (38.6) | 166.5 (39.0) | 172.2 (40.7) |
| Stage 3 | 25.6 (18.1) | 25.6 (18.8) | 23.8 (18.2) |
| Stage 4 | 15.6 (21.9) | 13.6 (21.0) | 12.9 (20.5) |
| REM | 59.4 (18.0) | 61.4 (20.1) | 58.3 (20.5) |
| Subjective sleep measures, mean (SD)11 | |||
| sWASO, min | 90.3 (54.2) | 88.4 (59.0) | 91.1 (66.0) |
| sTSO, min | 63.2 (54.2) | 71.6 (55.2) | 65.0 (62.9) |
| sTST, min | 326.2 (61.7) | 330.2 (64.3) | 328.9 (66.7) |
| sNAW, n | 2.4 (2.0) | 2.3 (1.1) | 2.4 (1.2) |
| sQUAL, 0–100; 100 best | 51.4 (13.4) | 52.0 (14.9) | 53.0 (14.6) |
| sFRESH, 0–100; 100 best | 49.7 (12.7) | 49.9 (15.2) | 50.0 (14.7) |
1
Mean of the first 2 nights of the single-blind placebo run-in period.
11
Mean of between 3 to 5 nights of the single-blind placebo run-in period. Sample sizes were slightly lower for these measures by approximately 20 patients per group, depending on the measure.