CompletedNot Applicable

Evaluation of an Herbal Extract on Sleep Parameters

Sweden52 participantsStarted 2023-09-10

Plain-language 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.

Who can participate

Age range35 Years – 60 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sleep onset latency

Timeframe: 2 weeks

Trial details

NCT IDNCT05829902

SponsorAventure AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-19