Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial

Table 2

Overview of mAIS parameter score changes from baseline (v2) to end of study (v5). for Mann-U test for independent groups; for analysis of variance with baseline as covariates, IQP-AO-101 vs. placebo comparison.

mAIS Parameters	IQP-AO-101	Placebo	values	values
	(n = 25)	(n = 25)
	v5-v2,	v5-v2,
	mean ± s.d.	mean ± s.d.
Item 1: Sleep induction	1.08 ± 1.22	0.56 ± 1.08	0.127	0.012
Item 2: Night awakening	1.32 ± 1.46	0.52 ± 1.36	0.058	0.012
Item 3: Early final awakening	1.16 ± 1.46	0.56 ± 1.23	0.106	< 0.001
Item 4: Overall sleep quality	1.64 ± 1.11	0.40 ± 1.08	<0.001	< 0.001
Night Parameter	5.20 ± 3.80	2.04 ± 3.16	0.001	< 0.001
(Composite score: Item 1-4)
Item 5: Daytime well-being	1.60 ± 1.12	0.48 ± 1.08	<0.001	< 0.001
Item 6: Daytime functioning	1.40 ± 1.22	0.16 ± 1.11	<0.001	< 0.001
Item 7: Daytime sleepiness	1.72 ± 1.31	0.76 ± 0.88	0.004	< 0.001
Item 8: Feeling refreshed	1.84 ± 1.31	0.56 ± 0.71	<0.001	< 0.001
upon awakening
Day Parameter	6.56 ± 4.10	1.96 ± 2.65	<0.001	< 0.001
(Composite score: Item 5-8)
Total score	11.76 ± 6.85	4.00 ± 4.80	<0.001	< 0.001