Sleep Onset Latency
Conditions
Keywords
Sleep Onset Latency (SOL), Herbal extract, Lemon balm
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.
Interventions
OTHERHerbal extract drink
30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily
OTHERPlacebo
30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily
Sponsors
Aventure AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time spent in different sleep stages | 2 weeks | These Parameters will be measured by using the Oura Ring |
| 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 |
Countries
Sweden
Outcome results
None listed