Table 2.
Post hoc analysis: sleep stage shifts, NAs, sleep quality, and refreshing nature of sleep by stimulant use (modified intent-to-treat population)
| Baseline | Week 3 | Week 8 | Week 13 | |||||
|---|---|---|---|---|---|---|---|---|
| Parameter | ON-SXB | Placebo | ON-SXB 6 g | Placebo | ON-SXB 7.5 g | Placebo | ON-SXB 9 g | Placebo |
| Sleep stage shifts | ||||||||
| Stimulant use | n = 66 | n = 53 | ||||||
| Baseline, mean (SD) | 59.2 (24.5) | 64.0 (22.8) | ||||||
| LSM change from baseline (SE) | − 8.4 (2.2) | 0.6 (2.4) | − 12.8 (3.0) | 3.4 (3.1) | − 19.6 (2.6) | 1.5 (2.6) | ||
| LSMD (95% CI) | − 9.0 (− 15.5 to − 2.5)** | − 16.2 (− 24.8 to − 7.6)*** | − 21.1 (− 28.5 to − 13.8)*** | |||||
| No stimulant use | n = 31 | n = 40 | ||||||
| Baseline, mean (SD) | 62.1 (21.0) | 55.3 (19.5) | ||||||
| LSM change from baseline (SE) | – 13.4 (2.8) | – 3.5 (2.5) | – 20.2 (3.6) | 2.8 (3.2) | – 23.4 (4.1) | 4.1 (3.6) | ||
| LSMD (95% CI) | − 16.9 (– 24.5 to – 9.3)*** | – 23.0 (– 32.8 to – 13.3)*** | − 27.6 (– 38.4 to – 16.7)*** | |||||
| NAs | ||||||||
| Stimulant use | n = 66 | n = 53 | ||||||
| Baseline, mean (SD) | 78.5 (46.4) | 76.4 (30.6) | ||||||
| LSM change from baseline (SE) | – 26.6 (4.2) | – 20.2 (4.5) | – 35.8 (4.2) | – 17.1 (4.4) | – 36.0 (4.6) | – 14.7 (4.5) | ||
| LSMD (95% CI) | – 6.4 (– 18.7 to 5.9) | – 18.8 (– 30.8 to – 6.8)** | – 21.3 (– 34.1 to – 8.5)*** | |||||
| No stimulant use | n = 31 | n = 40 | ||||||
| Baseline, mean (SD) | 89.0 (36.8) | 78.2 (46.7) | ||||||
| LSM change from baseline (SE) | – 40.2 (6.2) | – 20.7 (5.5) | – 45.6 (7.7) | – 23.5 (6.8) | – 46.0 (8.2) | – 17.0 (7.2) | ||
| LSMD (95% CI) | – 19.5 (– 36.0 to – 3.0)* | – 22.1 (– 42.6 to – 1.6)* | – 29.0 (– 50.8 to – 7.1)** | |||||
| VAS sleep qualitya | ||||||||
| Stimulant use | n = 66 | n = 53 | ||||||
| Baseline, mean (SD) | 54.7 (19.1) | 55.5 (19.0) | ||||||
| LSM change from baseline (SE) | 10.7 (1.3) | 5.4 (1.4) | 18.3 (1.6) | 10.9 (1.7) | 19.5 (1.9) | 13.0 (2.0) | ||
| LSMD (95% CI) | 5.4 (1.6–9.1)** | 7.4 (2.9–12.0)** | 6.5 (1.1–11.9)* | |||||
| No stimulant use | n = 31 | n = 40 | ||||||
| Baseline, mean (SD) | 51.8 (24.3) | 56.5 (27.0) | ||||||
| LSM change from baseline (SE) | 14.7 (2.1) | 4.5 (1.8) | 19.4 (2.8) | 6.2 (2.5) | 24.9 (3.2) | 8.2 (2.8) | ||
| LSMD (95% CI) | 10.2 (4.6–15.9)*** | 13.2 (5.7–20.8)*** | 16.7 (8.1–25.3)*** | |||||
| VAS refreshing nature of sleepa | ||||||||
| Stimulant use | n = 66 | n = 53 | ||||||
| Baseline, mean (SD) | 49.0 (20.4) | 50.9 (21.8) | ||||||
| LSM change from baseline (SE) | 11.5 (1.4) | 7.0 (1.6) | 20.5 (1.7) | 11.7 (1.8) | 22.6 (2.0) | 15.1 (2.1) | ||
| LSMD (95% CI) | 4.5 (0.3–8.7)* | 8.8 (3.9–13.6)*** | 7.6 (1.8–13.3)* | |||||
| No stimulant use | n = 31 | n = 40 | ||||||
| Baseline, mean (SD) | 41.3 (24.1) | 48.6 (25.3) | ||||||
| LSM change from baseline (SE) | 16.1 (2.4) | 6.4 (2.0) | 20.6 (3.4) | 6.1 (2.9) | 25.7 (3.8) | 8.8 (3.2) | ||
| LSMD (95% CI) | 9.7 (3.5–15.8)** | 14.5 (5.6–23.4)** | 16.9 (7.0–26.8)*** | |||||
Mixed-effects model for repeated measures used to assess significance at each timepoint
CI confidence interval, LSM least-squares mean, LSMD least-squares mean difference, NA nocturnal arousal, ON-SXB once-nightly sodium oxybate, REM rapid eye movement, SD standard deviation, SE standard error, VAS visual analog scale, *p < 0.05; **p ≤ 0.01; ***p < 0.001
aVAS of 1–100, with 1 indicating “did not sleep”/“not refreshed” and 100 indicating “slept very well”/“refreshed”