Evaluation of an Herbal Extract on Sleep Parameters in Healthy, Middle-aged Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Onset Latency
- Sponsor
- Aventure AB
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Sleep onset latency
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Sleep onset latency
Time Frame: 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 Outcomes
- Perceived alertness and wellbeing during the day(2 weeks)
- Time spent in different sleep stages(2 weeks)