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Completed

NCT Number: NCT05829902

Evaluation of an Herbal Extract on Sleep Parameters

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.

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Key information

Conditions

Sleep Onset Latency

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aventure Clinical Trial Unit

Lund, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herbal extract drink

Other

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

Placebo

Other

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

Primary outcomes

  1. Sleep onset latency

    Time frame: 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 outcomes

  1. Time spent in different sleep stages

    Time frame: 2 weeks

    These Parameters will be measured by using the Oura Ring

  2. Perceived alertness and wellbeing during the day

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aventure AB

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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