Table 1.
Post hoc analysis: change from baseline in time spent in sleep stages, delta power, REM, and REM latency (modified intent-to-treat population)
| Parameter | Week 0 | Week 3 | Week 8 | Week 13 | ||||
|---|---|---|---|---|---|---|---|---|
| ON-SXB n = 97 |
Placebo n = 93 |
ON-SXB 6 g n = 97 |
Placebo n = 93 |
ON-SXB 7.5 g n = 97 |
Placebo n = 93 |
ON-SXB 9 g n = 97 |
Placebo n = 93 |
|
| N1 sleep | ||||||||
| Time spent in N1 sleep at baseline, minutes | ||||||||
| Mean (SD) | 40.2 (22.1) | 42.6 (21.2) | ||||||
| Change from baseline in N1, minutes | ||||||||
| LSM (SE) | − 6.2 (1.7) | − 0.3 (1.7) | − 10.3 (2.0) | 0.73 (1.9) | − 13.2 (1.8) | 0.15 (1.7) | ||
| LSMD (95% CI) | − 5.9 (− 10.7 to − 1.1)* | − 11.0 (− 16.5 to − 5.5)*** | − 13.4 (− 18.4 to − 8.4)*** | |||||
| N2 sleep | ||||||||
| Time spent in N2 sleep at baseline, minutes | ||||||||
| Mean (SD) | 215.9 (52.2) | 211.6 (48.3) | ||||||
| Change from baseline in N2, minutes | ||||||||
| LSM (SE) | – 8.5 (4.1) | − 1.9 (4.1) | 2.7 (4.4) | − 1.0 (4.3) | − 11.5 (5.0) | 2.0 (4.7) | ||
| LSMD (95% CI) | − 6.6 (− 18.1 to 4.9) | 3.6 (− 8.4 to 15.7) | − 13.5 (− 27.1 to 0.1) | |||||
| N3 sleep | ||||||||
| Time spent in N3 sleep at baseline, minutes | ||||||||
| Mean (SD) | 68.8 (31.5) | 68.8 (28.1) | ||||||
| Change from baseline in N3, minutes | ||||||||
| LSM (SE) | 27.6 (3.0) | 5.5 (3.0) | 30.4 (3.7) | 3.6 (3.6) | 39.5 (4.3) | 1.1 (4.1) | ||
| LSMD (95% CI) | 22.1 (13.6–30.5)*** | 26.8 (16.6–37.0)*** | 38.4 (26.7–50.1)*** | |||||
| Delta power in NREM | ||||||||
| Baseline delta power in NREM | ||||||||
| Mean (SD) | 460.8 (336.8) | 545.6 (656.5) | ||||||
| Change from baseline in delta power in NREM | ||||||||
| LSM (SE) | 239.4 (62.4) | − 6.5 (63.5) | 400.3 (95.3) | 90.2 (101.3) | 640.8 (110.8) | 67.2 (106.3) | ||
| LSMD (95% CI) | 245.8 (69.0–422.7)** | 310.0 (33.3–586.7)* | 573.6 (266.8–880.4)*** | |||||
| Total REM sleep | ||||||||
| Total REM sleep at baseline, minutes | ||||||||
| Mean (SD) | 76.7 (30.8) | 78.3 (27.7) | ||||||
| Change from baseline in total REM sleep, minutes | ||||||||
| LSM (SE) | − 16.1 (2.6) | 0.6 (2.6) | − 21.3 (2.7) | 5.9 (2.7) | − 22.8 (3.3) | 1.7 (3.1) | ||
| LSMD (95% CI) | − 16.7 (− 23.9 to − 9.5)*** | − 27.2 (− 34.8 to − 19.6)*** | − 24.5 (− 33.4 to − 15.6)*** | |||||
| REM latency | ||||||||
| Baseline REM latency, minutes | ||||||||
| Mean (SD) | 69.1 (68.0) | 56.0 (45.9) | ||||||
| Change from baseline in REM latency, minutes | ||||||||
| LSM (SE) | 14.2 (6.8) | − 3.4 (6.8) | 19.7 (7.6) | − 3.4 (7.5) | 20.8 (8.6) | − 2.4 (8.1) | ||
| LSMD (95% CI) | 17.6 (− 1.4 to 36.6) | 23.1 (2.0–44.2)* | 23.2 (− 0.21 to 46.6) | |||||
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, NREM non-rapid eye movement, ON-SXB once-nightly sodium oxybate, REM rapid eye movement, SD standard deviation, SE standard error
*p < 0.05; **p < 0.01; ***p < 0.001