Table 6.
Treatment Effects on Sleep Architecture.
| Treatment | Placebo | 2.5 mg/day | 10 mg/day | p for Tx effect | |||
|---|---|---|---|---|---|---|---|
| Parameter | Base | EOT | Base | EOT | Base | EOT | |
| TST (min) | 364 ± 61 | 384 ± 59 | 384 ± 54 | 401 ± 55 | 398 ± 61 | 423 ± 42 | .98 |
| p vs Placebo | — | 0.85 | 0.77 | — | |||
| p vs 2.5 mg/day | — | — | 0.64 | — | |||
| Supine (min) | 204 ± 162 | 252 ± 144 | 216 ± 114 | 186 ± 102 | 222 ± 132 | 234 ± 132 | .93 |
| p vs Placebo | — | 0.65 | 0.98 | — | |||
| p vs 2.5 mg/day | — | — | 0.76 | — | |||
| Efficiency | 76 ± 13 | 80 ± 14 | 80 ± 11 | 83 ± 11 | 83 ± 12 | 88 ± 10 | .91 |
| p vs Placebo | — | 0.80 | 0.92 | — | |||
| p vs 2.5 mg/day | — | — | 0.71 | — | |||
| SOL (min) | 14.3 ± 17.2 | 18.8 ± 33.6 | 16.8 ± 17.1 | 16.0 ± 18.7 | 8.6 ± 8.5 | 20.8 ± 31.8 | .14 |
| p vs Placebo | — | 0.54 | 0.39 | — | |||
| p vs 2.5 mg/day | — | — | 0.12 | — | |||
| REML (min) | 98 ± 52 | 114 ± 71 | 109 ± 60 | 89 ± 42 | 109 ± 69 | 83 ± 57 | .16 |
| p vs Placebo | — | 0.38 | 0.18 | — | |||
| p vs 2.5 mg/day | — | — | 0.91 | — | |||
| WASO (min) | 100 ± 52 | 71 ± 46 | 78 ± 48 | 61 ± 47 | 74 ± 58 | 42 ± 33 | .85 |
| p vs Placebo | — | 0.46 | 0.84 | — | |||
| p vs 2.5 mg/day | — | — | 0.32 | — | |||
| NREM% | 78.7 ± 6.8 | 81.3 ± 7.7 | 81.0 ± 4.7 | 76.9 ± 5.8 | 78.9 ± 4.7 | 77.0 ± 6.0 | .04 |
| p vs Placebo | — | 0.006 | 0.06 | — | |||
| p vs 2.5 mg/day | — | — | 0.33 | — | |||
| SWS% | 18.0 ± 9.0 | 14.6 ± 9.5 | 15.4 ± 7.4 | 15.9 ± 9.1 | 17.6 ± 7.8 | 17.4 ± 8.1 | .71 |
| p vs Placebo | — | 0.17 | 0.25 | — | |||
| p vs 2.5 mg/day | — | — | 0.78 | — | |||
| REM% | 21.3 ± 6.8 | 18.7 ± 7.7 | 19.0 ± 4.7 | 23.1 ± 5.8 | 21.1 ± 4.7 | 23.0 ± 6.0 | .04 |
| p vs Placebo | — | 0.006 | 0.06 | — | |||
| p vs 2.5 mg/day | — | — | 0.33 | — | |||
| Arousal index | 35.9 ± 23.2 | 37.8 ± 19.5 | 31.9 ± 21.4 | 42.7 ± 23.4 | 30.3 ± 16.3 | 33.8 ± 19.5 | .28 |
| p vs Placebo | — | 0.19 | 0.83 | — | |||
| p vs 2.5 mg/day | — | — | 0.24 | — | |||
| SpO2 < 85% (min) | 3.0 ± 7.4 | 4.2 ± 4.1 | 3.6 ± 7.3 | 3.4 ± 7.8 | 4.7 ± 10.0 | 4.5 ± 10.1 | .53 |
| p vs Placebo | — | 0.36 | 0.35 | — | |||
| p vs 2.5 mg/day | — | — | 0.99 | — | |||
| Mean SpO2 nadir | 91.6 ± 2.5 | 91.2 ± 2.7 | 90.9 ± 2.8 | 90.7 ± 2.8 | 91.2 ± 2.4 | 90.3 ± 2.9 | .47 |
| 0.79 | 0.46 | — | |||||
| p vs 2.5 mg/day | — | — | 0.30 | — | |||
Values are mean ± standard deviation.
Tx = treatment; EOT = end of treatment; Base = baseline value; TST = total sleep time; Supine = duration of supine sleep; Efficiency = sleep efficiency; SOL = sleep onset latency; REML = REM latency from sleep onset; WASO = wake after sleep onset; NREM% = percent total sleep time spent in NREM sleep; REM% = percent total sleep time spent in REM sleep; SpO2 = oxygen saturation by pulse oximetry.