single-center, randomized, cross over, double-blind, placebo controlled intervention study
The single-center, randomized, cross over, double-blind, placebo controlled intervention study will include 70 subjects who will test the efficacy of three formulations on sleep quality parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
1 capsule (placebo)
1 capsule (melatonin)
1 capsule (valerian root extract)
CMS - Center za motnje spanja
Ljubljana, Slovenia
Difference in sleep onset latency (SOL) compared to placebo
Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
Time frame: 2 weeks
Difference in sleep quality compared to placebo
Difference in sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI; ranking from 0 \[best\] to 21 \[worst\])
Time frame: 2 weeks
Difference in sleep efficiency (SE) compared to placebo
Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy
Time frame: 2 weeks
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