Effect of melatonin on insomnia and daytime sleepiness, in patients with obstructive sleep apnea and insomnia (COMISA): A randomized double-blinded placebo-controlled trial

Table 3 Secondary outcomes results

	Arms						Mean Difference (SD) (CI 95%)	Pvalue¹	Effect size (95% CI)²
Secondary outcomes	Melatonin (Mean±SD)			Placebo (Mean±SD)
	Before	After	P value³	Before	After	P value³
AHI (events/hr.)	4.91±3.50	3.84±3.54	0.018	5.05±9.25	4.99±9.36	0.937	-1.06(2.66, -6.54 to 4.41)	0.683	1.141 (0.344,1.867)
Mean total sleep time absolute deviation (hr.)⁴	1.274	1.142	0.434	1.047	1.336	0.166	-	0.769	0.296 (-0.453, 1.037)
Total sleep time (hr.)	6.75±1.52	7.64±1.39	-	5.92±1.19	6.46±1.646	-	-	-	0.920(0,130,1.693)
Sleep efficiency (percent)⁵	79.66± 15.39	91.33± 8.73	0.001	74.33± 18.44	80.40±15.19	0.010	10.93 (4.5, 1.66 to 20.20)	0.011	0.314 (-0.409, 1.039)

¹ P value between groups, Mann–Whitney
² The effect size is based on Cohen's d
³ Pvalue within group, Wilcoxon test
⁴Mean deviations used to calculate the average deviation from the mean value of total sleep time. It helps to calculate the mean difference between pre-and post-intervention
⁵ Sleep efficiency considered the percentage of time spent asleep while being in bed. It is calculated by the division of the amount of time that patients maintained asleep by the total amount of time stayed in bed. The normal sleep efficiency is more than 85%

ISSN: 2055-0294