Study to determine the presence of a hang-over effect in healthy volunteers the day after the administration of Songha® Night
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Changes from baseline of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test
Time frame: 08:00h, 09:30h, 11:00h at Day 7 of each treament period
Change of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test
Time frame: up to day 36
Change in subjective sleepiness rated on a 7 point scale
Stanford Sleepiness Scale
Time frame: up to day 36
Change in subjective sleepiness measured on a visual analogue scale (VAS)
Time frame: up to day 36
Change in sleep quality measured on a visual analogue scale (VAS)
Time frame: up to day 36
Global Assessment of tolerability by investigator on 4-point scale
Time frame: Day 36
Global Assessment of tolerability by patient on 4-point scale
Time frame: Day 36
Number of subjects with adverse events
Time frame: up to 36 days
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