Table 2.

Change of objective sleep parameters between the zonisamide treatment and placebo groups on the full analysis set (FAS).

	zonisamide treatment			placebo
	baseline (n = 23)	28 days (n = 19)	quantity of alteration (n = 15) a	baseline (n = 22)	28 days (n = 22)	quantity of alteration (n = 16) a	p*
dropouts number (n)	10	14	18	12	12	18
primary outcome
sleep efficiency (%)	82.81 ± 16.33	83.59 ± 14.16	0.21 ± 12.35	86.45 ± 8.38	85.19 ± 11.36	−2.45 ± 12.53	0.556
secondary outcomes objective outcome
Total sleep time (TST) (min)	321.87 ± 84.89	313.84 ± 105.23	−11.77 ± 72.10	348.30 ± 103.96	339.50 ± 115.68	−15.28 ± 81.81	0.9
Wake time after sleep onset (WASO) (min)	72.96 ± 77.79	64.71 ± 56.51	−8.73 ± 60.65	54.14 ± 33.78	60.67 ± 56.81	11.69 ± 65.02	0.374
Sleep onset latency (SOL) (min).	30.70 ± 29.13	21.84 ± 17.43	−2.17 ± 23.59	32.57 ± 43.61	37.61 ± 51.24	3.69 ± 31.82	0.567
REM sleep/non-REM sleep ratio (%)	20.75 ± 12.27	16.66 ± 15.78	−1.7 ± 17.18	17.98 ± 13.44	20.62 ± 9.78	−0.42 ± 11.09	0.805
Deep sleep (N3) time (min)	69.30 ± 30.03	66.50 ± 38.25	−8.90 ± 33.08	68.09 ± 29.84	55.23 ± 27.63	−13.91 ± 37.84	0.699

* comparison of quantity of alteration between zonisamide treatment and placebo groups.

a: the quantity of alteration of the EEG/EOG recording system was analyzed patients who had both pre- and post-intervention data.