Evaluation of an Herbal Extract on Sleep Parameters

• Sponsor: Aventure AB (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05829902
• Collaborator: (none)
• Enrollment: 70
• Arms: 2
• Anticipated Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Onset Latency	Other: Herbal extract drink; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Other
• Official Title: Evaluation of an Herbal Extract on Sleep Parameters in Healthy, Middle-aged Women
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sleep onset latency [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 Outcome Measures

1. Time spent in different sleep stages [2 weeks]

   These Parameters will be measured by using the Oura Ring

2. Perceived alertness and wellbeing during the day [2 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aventure AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aventure AB
• ClinicalTrials.gov Identifier: NCT05829902
• Other Study ID Numbers: Sleepwell_2023
• First Posted: Apr 26, 2023
• Last Update Posted: Apr 26, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aventure AB: Sleep Onset Latency (SOL); Herbal extract; Lemon balm

Study Results

No Results Posted as of Apr 26, 2023