Evaluation of an Herbal Extract on Sleep Parameters

Evaluation of an Herbal Extract on Sleep Parameters in Healthy, Middle-aged Women

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.

Study Overview

• Status: Completed
• Conditions: Sleep Onset Latency
• Intervention / Treatment: Other: Herbal extract drink; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Aventure Clinical Trial Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active product; 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.	Other: Herbal extract drink; 30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily
Placebo Comparator: Placebo; 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.	Other: Placebo; 30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep onset latency	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	2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aventure AB

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Actual): June 19, 2024
• Study Completion (Actual): June 24, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Sleep Onset Latency (SOL); Herbal extract; Lemon balm
• Other Study ID Numbers: Sleepwell_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No