Table 3.

Efficacy Measures of RBD Activity Per RBD Logs and Video-Polysomnography

		Median [IQR]
		Sodium oxybate			Placebo			Sodium oxybate vs. placebo
		Baseline n = 12	Final Dose n = 10	Change (95% CI), pa	Baseline n = 12	Final Dose n = 12	Change (95% CI), pa	Difference in Changeb (95% CI)	p c
RBD logs	RBD Episodes per Month	37.5 [27.5 to 48.5]	23.5 [6 to 47]	−23.5 (−41.0 to −2.0), 0.03	35 [28.5 to 45.5]	25.5 [14.5 to 46]	−9.0, (−21.5 to 0.0), 0.11	−14.5 (−32.0 to 11.3)	0.27
	Overall Severity Burden	89.5 [63 to 193.5]	53 [14 to 150]	−46.5 (−85.0 to −19.0), 0.01	121 [78.5 to 149.5]	94.5 [45 to 138]	−34.5 (−52.5 to 1.5), 0.08	−12 (−60.0 to 21.5)	0.46
	Severe Episode Burden	1.5 [0.5 to 4.0]	0.5 [0 to 1]	−1 (−3 to 0), 0.02	1.5 [0 to 3.5]	1.0 [0 to 2.5]	0 (−1 to 1), 0.83	−1 (−3.5 to 0.0)	0.09
		Baseline n = 10	Final dose n = 7	Change (95% CI), pe	Baseline n = 10	Final dose n = 9	Change (95% CI), pe	Difference in Changef (95% CI)	p g
Video-PSGd	Video Total Movements	55.5 [18 to 82]	16 [0 to 50]	−25 (−90 to −4), 0.03	57.5 [24 to 269]	25 [16 to 153]	−24 (−61 to 11), 0.15	−1.0 (−82 to 46)	0.72
	Video Movements per 10 minutes	13.2 (12.3)	7.2 (7.4)	−6.2 (−15.2 to 1.7), 0.23	10.1 (8.4)	10.5 (10.0)	0.2 (−4.6 to 4.5), 0.95	−6.4 (−16.2 to 3.1)	0.22
	REM sleep minutes	53.8 (20.1)	31.6 (30.1)	−24.5 (−35.7 to −12.2), 0.01	107.5 (57.2)	81.2 (32.6)	−32.6 (−63.4 to −0.7), 0.09	8.1 (−25.2 to 40.8)	0.67

IQR, interquartile range; PSG, polysomnography.

^a P-value for within-group change, Wilcoxon Signed Rank test.

^bnegative values favor sodium oxybate group.

^c P-value for difference between-group comparison, Mann–Whitney U test.

^dmean (SD) for normal data in both groups.

^e P-value for within-group change, paired t-tests.

^fNegative values favor sodium oxybate group.

^g P-value for difference between-group comparison, unpaired t-test.