Baseline objective polysomnographic (PSG) data. All results reported as mean (SD). Non-missing data reported.
| Polysomnographic Data | All Randomized Patients | Patients Who Completed the Study |
|---|---|---|
| No. patients | 195 | 151 |
| Objective sleep/wake outcome measures | (n = 181) | (n = 138) |
| Total sleep time, min | 362.9 (74.9) | 367.2 (72.6) |
| Sleep onset latency, min | 26.0 (27.0) | 24.7 (26.8) |
| Wake after sleep onset, min | 73.8 (55.2) | 75.5 (53.4) |
| No. awakenings | 25.5 (11.6) | 25.8 (11.6) |
| Sleep efficiency, % | 76.5 (15.5) | 77.2 (15.0) |
| Duration of sleep stages assessed by PSG | (n = 180) | (n = 136) |
| Rapid eye movement (REM), min | 76.1 (32.9) | 77.5 (33.8) |
| Non-REM, min | 286.9 (59.7) | 289.6 (58.6) |
| Stage 1, min | 41.2 (21.5) | 42.1 (22.7) |
| Stage 2, min | 203.1 (55.9) | 206.4 (56.0) |
| Slow-wave sleep, min | 42.5 (34.7) | 41.1 (30.4) |
| Rate of cyclic alternating pattern (CAP) | (n = 88) | (n = 47) |
| Total CAP rate | 62.7 (21.7) | 65.3 (17.5) |
| Phase A1 CAP rate, % | 48.4 (20.0) | 52.4 (16.7) |
| Phase A2/A3 CAP rate, % | 14.3 (7.7) | 12.9 (5.3) |