Sleep Onset LatencyNCT05829902
Evaluation of an Herbal Extract on Sleep Parameters
A study testing Herbal extract drink in people with Sleep Onset Latency, run by Aventure AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Onset Latency
- What is being tested?
- Herbal extract drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- 10 Sep 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Herbal Extract on Sleep Parameters in Healthy, Middle-aged Women
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
- Being tested
- Herbal extract drink, Placebo
- Keywords
- Sleep Onset Latency (SOL), Herbal extract, Lemon balm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal extract drinkOther
30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily
PlaceboOther
30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (2)
Time spent in different sleep stages
These Parameters will be measured by using the Oura Ring
Measured: 2 weeks
Perceived alertness and wellbeing during the day
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start10 Sep 2023
- Primary completion19 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Onset LatencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aventure AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829902
- Sponsor's protocol ID
- Sleepwell_2023
- Status last verified
- Jan 2025
- First submitted
- 29 Mar 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Herbal Extract on Sleep Parameters in Healthy, Middle-aged Women
- ClinicalTrials.gov ID
- NCT05829902
- Acronym / sponsor ID
- Sleepwell_2023
- Conditions
- Sleep Onset Latency
- Keywords
- Sleep Onset Latency (SOL), Herbal extract, Lemon balm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aventure ABIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active product | Experimental | Other: Herbal extract drinkThe 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. |
| Placebo | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal extract drink30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily | Other | Active product |
| Placebo30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily | Other | Placebo |
Primary outcome
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
2 secondary outcomes
Time spent in different sleep stages
Time frame: 2 weeks
Perceived alertness and wellbeing during the day
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal extract drink in people with Sleep Onset Latency, run by Aventure AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset latency (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.