Evaluation of an Herbal Extract on Sleep Parameters

Not Applicable

Completed

• Conditions: Sleep Onset Latency

• Registration Number: NCT05829902
• Lead Sponsor: Aventure AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-26
• Study Start: 2023-09-10
• Primary Completion: 2024-06-19
• Study Completion: 2024-06-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• Female
• Age 35-60
• BMI 18-30 kg/m2
• Mild to moderate insomnia according to the ISI (Insomnia Severity Index) questionnaire (ISI-value 10-21)
• Matching results from the Oura ring and sleep diaries during the run-in period

Exclusion Criteria

• Metabolic disease (diabetes, cardiovascular disorders, hypo- or hyperthyroidism, etc)
• Severe psychiatric disorders
• Pregnancy, breastfeeding
• Restless legs or leg cramps that influence sleep and everyday life
• Conditions that prevent sleep through the symptoms that they produce (pain, nightly coughs, etc)
• Breathing problems (asthma, severe snoring, sleep apnea, etc)
• Medication that can influence sleep and/or wakefulness
• Consumption of herbal sedatives during the last month
• Having someone in the household that needs to be tended to during the night and pose a major risk to disturb the research participant's sleep to a large extent.
• Irregular work hours, including shift work at night
• Regularly sleeping more than 1 night per week away from home
• Tobacco or drug use
• Other factors that are deemed to influence participation negatively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep onset latency	2 weeks	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

Secondary Outcome Measures

Name	Time	Method
Perceived alertness and wellbeing during the day	2 weeks	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 spent in different sleep stages	2 weeks	These Parameters will be measured by using the Oura Ring

Trial Locations

Locations (1)

Aventure Clinical Trial Unit; 🇸🇪 Lund, Sweden