Table 1.
Baseline Characteristics of Patients in the Adult Study
|
Placebo (N = 156) |
Gaboxadol 10 mg (N = 154) |
Gaboxadol 15 mg (N = 148) |
|
|---|---|---|---|
| Demographics | |||
| Mean (SD) age, y | 43.5 (11.0) | 45.3 (11.6) | 42.8 (10.4) |
| Mean (SD) body mass index, kg/m2 | 25.9 (4.0) | 26.5 (3.7) | 26.4 (3.9) |
| Female, % | 66.7 | 64.9 | 66.9 |
| White, % | 62.8 | 57.1 | 56.8 |
| PSG sleep measures, mean (SD)1 | |||
| WASO, min | 102.4 (37.5) | 102.2 (34.4) | 101.0 (39.1) |
| LPS, min | 69.4 (37.4) | 64.6 (37.8) | 66.5 (33.3) |
| TST, min | 315.4 (52.8) | 319.1 (45.0) | 319.1 (49.3) |
| NAW, n | 16.2 (6.7) | 16.4 (5.8) | 15.1 (5.7) |
| SWS, min | 42.6 (27.3) | 42.9 (28.7) | 46.2 (29.9) |
| Sleep architecture, mean (SD) min in each stage1 | |||
| Stage 1 | 37.7 (18.1) | 38.2 (18.2) | 37.2 (17.5) |
| Stage 2 | 174.3 (41.5) | 177.3 (39.7) | 171.4 (40.9) |
| Stage 3 | 24.8 (14.4) | 25.1 (15.7) | 25.8 (15.9) |
| Stage 4 | 17.8 (21.8) | 17.7 (23.1) | 20.4 (23.0) |
| REM, | 60.8 (21.9) | 60.4 (20.0) | 64.3 (22.2) |
| Subjective sleep measures, mean (SD)11 | |||
| sWASO, min | 71.6 (53.7) | 71.6 (43.3) | 75.6 (54.6) |
| sTSO, min | 77.8 (46.0) | 67.2 (32.2) | 69.5 (39.4) |
| sTST, min | 322.4 (64.8) | 338.3 (59.3) | 333.1 (64.1) |
| sNAW, n | 2.2 (1.3) | 2.4 (1.4) | 2.4 (1.6) |
| sQUAL, 0–100; 100 best | 51.3 (16.3) | 51.4 (14.9) | 48.9 (15.1) |
| sFRESH, 0–100; 100 best | 45.5 (17.1) | 45.3 (15.9) | 47.0 (15.3) |
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 10 patients per group, depending on the measure.