Evaluation of an Herbal Extract on Sleep Parameters

NCT05829902 | Completed

• 1 other identifier: Sleepwell_2023
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Onset Latency

Keywords

Sleep Onset Latency (SOL); Herbal extract; Lemon balm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time spent in different sleep stages

  2 weeks

• Perceived alertness and wellbeing during the day

  2 weeks

Study Arms (2)

Active product

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Herbal extract drink OTHER

30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily

Active product

Placebo OTHER

30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aventure AB: lead

Study Sites (1)

Aventure Clinical Trial Unit

Lund, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A copy of the randomization list will be provided to those packing the product kits. The randomization list is a document that consists of randomization numbers, which uniquely assign each study patient to one of the treatments. The sponsor and all staff directly involved in the trial will thus be blinded to the product allocated to the participants. The randomization number will be documented.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 26, 2023
• Study Start: September 10, 2023
• Primary Completion: June 19, 2024
• Study Completion: June 24, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)