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 30 subjects who will test the efficacy of three formulations with different dosages of melatonin on sleep quality parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
1 spray (0 mg melatonin)
1 spray (1 mg melatonin)
1 spray (0.3 mg melatonin)
CMS - Center za motnje spanja
Ljubljana, Slovenia
RECRUITINGChange in sleep onset latency (SOL) compared to placebo
Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
Time frame: last 7 days of intervention
Changed sleep quality compared to placebo
Changed sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI)
Time frame: 14 days
Changed sleep efficiency (SE) compared to placebo
Changed sleep efficiency (SE) compared to placebo - assessed by actigraphy
Time frame: last 7 days of intervention
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