The overall purpose of this interventional study is to investigate how a specific herbal extract influences the quality of sleep in middle-aged women with mild to moderate insomnia. During the study, the participants are asked to take the test drink every night for two weeks. Both objective (Oura ring) and subjective (analog sleep diaries, questionnaires) measures are included to evaluate sleep parameters as well as perceived alertness and impact on daily functions. The primary outcome is sleep onset latency (SOL), which is the time it takes for a person to fall asleep. Secondary outcomes which will be evaluated include time spent in different sleep stages, number of times waking up during the night, and various qualitative ratings of energy levels and mood during the day. Researchers will compare the group with active product and placebo product to see if the consumption of the herbal extract will lead to improvements in the factors mentioned above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily
30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily
Aventure Clinical Trial Unit
Lund, Sweden
Sleep onset latency
The length of time it takes a person to fall asleep when turning the lights off, this parameter will be measured by using the Oura Ring
Time frame: 2 weeks
Time spent in different sleep stages
These Parameters will be measured by using the Oura Ring
Time frame: 2 weeks
Perceived alertness and wellbeing during the day
These parameters will be measured by using a sleep diary (pen and paper) with a ranking scale which needs to be filled out in the morning and in the evening
Time frame: 2 weeks
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