The objective of this pilot clinical trial is to evaluate the potential of IQP-AO-101 with respect to sleep-promoting effects in subjects with sleep complaints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
1 dose (sachet) to be consumed 30 - 60 mins before bedtime
1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product)
Analyze & Realize
Berlin, Germany
Change in mAIS parameters at V5 vs V2
Change in modified Athens Insomnia Scale parameters
Time frame: 6 weeks
Change in mAIS parameter at V3 and V4, vs V2
Change in modified Athens Insomnia Scale parameters
Time frame: 1 week, 4 weeks
Change in activity tracker sleep parameters
Use of an activity tracker to monitor sleep and compare against baseline
Time frame: 1 week, 6 weeks
Change in FAIR-2
Change in FAIR-2 at each visit
Time frame: 1 week, 4 weeks, 6 weeks
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