Clinical trial NCT05829902: Evaluation of an Herbal Extract on Sleep Parameters
Official title: Evaluation of an Herbal Extract on Sleep Parameters in Healthy, Middle-aged Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Onset Latency
Keywords: Sleep Onset Latency (SOL)
Herbal extract
Lemon balm
Lead sponsor: Aventure AB
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 52
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep onset latency
timeFrame: 2 weeks
Secondary outcomes:
measure: Time spent in different sleep stages
timeFrame: 2 weeks
measure: Perceived alertness and wellbeing during the day
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Aventure Clinical Trial Unit
Study officials:
References: