Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-03-29
Brief Title:
Evaluation of an Herbal Extract on Sleep Parameters
Sponsor:
Aventure AB
Organization:
Aventure AB
Study Overview
Official Title:
Evaluation of an Herbal Extract on Sleep Parameters in Healthy Middle-aged Women
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None