Evaluation of an Herbal Extract on Sleep Parameters

Aventure

Status: Completed

Conditions: Sleep Onset Latency

Treatments: Other: Herbal extract drink; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05829902

Sleepwell_2023

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Active product

Experimental group

Description:

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.

Treatment:

Other: Herbal extract drink

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo