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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active product | Experimental | The active product is a drink consisting of 600 mg of lemon balm extract, tea leaves, brown sugar and powdered flavoring agent that is mixed with lukewarm water. The volume per serving is 30 ml. The drink will be taken every night before sleep for a period of two weeks. |
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| Placebo | Placebo Comparator | The placebo drink is maltodextrin mixed with water, and the same tea leaves, brown sugar and powdered flavoring agent as the test drink. The volume per serving is 30 ml. The drink will be taken every night before sleep for a period of two weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal extract drink | Other | 30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in different sleep stages | These Parameters will be measured by using the Oura Ring | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aventure Clinical Trial Unit | Lund | Sweden |
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This study is a randomized, placebo-controlled, parallel intervention with two arms. The study is divided into three phases: the run-in period (14 days), the intervention period (14 days) and the follow-up period (14 days). Eligible participants will be randomized in a 1:1 ratio to receive either lemon balm extract or a placebo. Randomization will be stratified by ISI-value and age at baseline. Treatment assignments will be pre-planned according to a computer-generated randomization scheme prepared by a vendor.
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A copy of the randomization list will be provided to those packing the product kits. The randomization list is a document that consists of randomization numbers, which uniquely assign each study patient to one of the treatments. The sponsor and all staff directly involved in the trial will thus be blinded to the product allocated to the participants. The randomization number will be documented.
| Placebo | Other | 30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily |
|
| 2 weeks |