Sleep Disorder (Disorder)Phase 2NCT07315516
Sleep and Stress Study
A Phase 2 study testing Lavender Oil, Palmitoylethanolamide (PEA) and Oleoylethanolamide in people with Sleep Disorder (Disorder) and Stress, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
The goal of this clinical trial is to learn if natural supplements (lavender oil, PEA, and OEA) work to improve sleep and reduce stress in adults with moderate stress levels and sleep difficulties. It will also learn about the safety of these natural supplements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder (Disorder), Stress, Anxiety
- What is being tested?
- Lavender Oil, Palmitoylethanolamide (PEA) and Oleoylethanolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Apr 2026to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy adults aged 18 and over.
- Able to provide informed consent.
- Score of at least 14 on the Perceived Stress Scale (PSS).
- Those with a sleep complaint with a frequency of at least 2 times per week(1)
- Agree not to use other dietary supplements for sleep, depression, stress or anxiety other than the investigational product during entire study period.
- Agree not to change current diet and/or exercise frequency or intensity during entire study period.
- Agree to not participate in another clinical trial during the study period.
- Sleep complaints are defined as difficulty initiating sleep, or difficulty maintaining sleep, or early-morning awakening with inability to return to sleep and causing distress or impairment in social, occupational, educational, academic, behavioural, or other important areas of functioning.)
Who cannot join
- A WHO-5 Well-Being Index score ≤ 28
- Those with severe sleep complaints (Insomnia Severity Index >21)
- Taking prescribed sleep, depression or anxiety medication
- Have a serious illness e.g. asthma, depression, anxiety disorder, bipolar disorder, insomnia, organic sleep disorders (i.e. sleep apnoea), neurological disorders such as MS, kidney disease, liver disease or heart conditions
- Have an unstable illness e.g. diabetes and thyroid gland dysfunction
- Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
Show all 14Show fewer
- Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
- Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- Chronic past and/or current alcohol use (>21 alcoholic drinks week)
- Those consuming more than 500mg caffeine per day
- Pregnant or lactating women
- Allergic to any of the ingredients in active or placebo formula
- Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
RDC Clinical
Brisbane
Amanda Rao, PhD, +61 (07) 3102 4486, research@rdcglobal.com.au
Amanda Rao, PhD
About this study
Official title: The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial
The goal of this clinical trial is to learn if natural supplements (lavender oil, PEA, and OEA) work to improve sleep and reduce stress in adults with moderate stress levels and sleep difficulties. It will also learn about the safety of these natural supplements.
The main questions it aims to answer are:
Read more
- Do these supplements improve sleep quality?
- Do they reduce perceived stress levels?
- Do they reduce anxiety symptoms?
- What medical problems do participants have when taking these supplements?
Researchers will compare three active treatment groups (lavender oil, PEA, Trpti which contains OEA) to a placebo (a look-alike capsule that contains no active ingredients) to see if these natural supplements work to improve sleep and reduce stress.
Participants will take 1 capsule (either active supplement or placebo) every day for 8 weeks and attend 2 clinic visits with a phone check in in between.
Read the detailed description
The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial This four-arm, parallel-group trial evaluates bioactive compounds targeting stress-sleep pathophysiology (lavender oil, PEA, and OEA). The 8-week intervention employs validated psychometric instruments alongside salivary biomarkers providing objective HPA axis and circadian rhythm assessment. The trial enrolls 240 participants (60 per arm) with moderate stress (PSS ≥14) and sleep complaints.
- Conditions
- Sleep Disorder (Disorder), Stress, Anxiety
- Being tested
- Lavender Oil, Palmitoylethanolamide (PEA), Oleoylethanolamide, Placebo
- Keywords
- Sleep complaints
- Medical subject headings
- Sleep Wake Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender OilDietary supplement
Also called CPO Lavender oil
85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Palmitoylethanolamide (PEA)Dietary supplement
Also called Levagen+
75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
OleoylethanolamideDietary supplement
Also called Trpti
150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days
PlaceboOther
A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.
| Study group | Role | What they receive |
|---|---|---|
| CPO Lavender oil | Experimental | 85mg CPO Lavender oil will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. Receives: Dietary Supplement: Lavender Oil |
| Levagen+ PEA | Experimental | 75mg Levagen+ PEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. Receives: Dietary Supplement: Palmitoylethanolamide (PEA) |
| Trpti OEA | Experimental | 150mg Trpti OEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. Receives: Dietary Supplement: Oleoylethanolamide |
| Placebo | Placebo comparator | A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress via Perceived Stress Scale (PSS)
Change from baseline to the end of the study period in Perceived stress via Perceived Stress Scale (PSS). The Perceived Stress Scale is a self-reported tool for measuring psychological stress. A total PSS-10 score from 0 to 40 is presented, with higher scores representing higher levels of stress.
Measured: Day 1 to day 57
Anxiety via Beck Anxiety Inventory (BAI)
Change from baseline to the end of the study period in Anxiety via Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report questionnaire evaluating anxiety symptoms, rated on a 4-point scale.
Measured: Day 1 to day 57
Sleep quality
Change from baseline to the end of the study period in Sleep quality. This will be measured via Pittsburgh Sleep Quality Index (PSQI) and Consensus Sleep Diary. The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns.
Measured: Day 1 to day 57
Secondary outcomes (15)
Mental wellbeing
Change from baseline to the end of the study period in Mental wellbeing via The World Health Organization-Five Well-Being Index (WHO-5). The WHO-5 is a self-report instrument measuring mental well-being. It consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being. A score ≤ 50 (or < 13 in the raw score) is associated with poor well-being or psychological distress and a score ≤ 28 may denote possible clinical symptoms of depression.
Measured: Day 1 to day 57
Mood
Change from baseline to the end of the study period in Mood via Profile of mood states (POMS). The POMS is a self-reported questionnaire consisting of 65 items, designed to evaluate individuals within seven different mood domains: fatigue-inertia, anger-hostility, vigor-activity, confusion-bewilderment, depression-dejection, tension-anxiety, and friendliness.
Measured: Day 1 to day 57
Sleep duration
Change from baseline to the end of the study period in Sleep duration via PSQI and Consensus Sleep Diary. The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns.
Measured: Day 1 to day 57
Sleep onset latency
Change from baseline to the end of the study period in Sleep onset latency as measured by duration of time (minutes) from turning light off to falling asleep (PSQI and Consensus Sleep Diary). The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns.
Measured: Day 1 to day 57
Sleep efficiency
Change from baseline to the end of the study period in Sleep efficiency as measured by ratio of total sleep time to time in bed (PSQI). The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: Day 1 to day 57
Daytime sleepiness
Change from baseline to the end of the study period in Daytime sleepiness via Functional Outcomes of Sleep Questionnaire (FOSQ-10). The FOSQ-10 consists of 10 items distributed among 5 subscales i.e. general productivity (2 item), activity level (3 items), vigilance (3 items), social outcomes (1 item) and sexual relationship (1 item). Items are rated on a scale of 1-4 (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, 4 = no difficulty). The total score is the sum of the 5 sub scores.
Measured: Day 1 to day 57
Eating in response to experienced stress
Change from baseline to the end of the study period in Eating in response to experienced stress via the Salzburg Stress Eating Scale (SSES). The SSES is a questionnaire use to measure eating in response to experienced stress. The response categories range from 'I eat much less than usual' to 'I eat much more than usual' and are scored on a 5-point Likert scale, i.e., a score from 1 - 5. Higher scores indicate that the respondent eats more when stressed is experienced.
Measured: Day 1 to day 57
Serotonin
Change from baseline to the end of the study period in serotonin via saliva test.
Measured: Day 1 to day 57
Cortisol
Change from baseline to the end of the study period in cortisol via saliva test.
Measured: Day 1 to day 57
Melatonin
Change from baseline to the end of the study period in melatonin via saliva test.
Measured: Day 1 to day 57
Safety via AE monitoring
Change from baseline to the end of the study period in Safety via AE monitoring
Measured: Day 1 to day 57
Safety via vital signs (blood pressure)
Change from baseline to the end of the study period in safety via vital signs (blood pressure).
Measured: Day 1 to day 57
Safety via vital signs (heart rate)
Change from baseline to the end of the study period in safety via vital signs (heart rate).
Measured: Day 1 to day 57
Safety via vital signs (O2 saturation)
Change from baseline to the end of the study period in safety via vital signs (O2 saturation).
Measured: Day 1 to day 57
Safety via vital signs (temperature)
Change from baseline to the end of the study period in safety via vital signs (temperature).
Measured: Day 1 to day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start7 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Responsible party
- Sponsor
- Investigators
- RV Venkatesh, Study director, Gencor Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315516
- Sponsor's protocol ID
- EVESLE
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07315516
- Acronym / sponsor ID
- EVESLE
- Conditions
- Sleep Disorder (Disorder), Stress, Anxiety
- Keywords
- Sleep complaints
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Jan 2026 (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 goal of this clinical trial is to learn if natural supplements (lavender oil, PEA, and OEA) work to improve sleep and reduce stress in adults with moderate stress levels and sleep difficulties. It will also learn about the safety of these natural supplements.
The main questions it aims to answer are:
- Do these supplements improve sleep quality?
- Do they reduce perceived stress levels?
- Do they reduce anxiety symptoms?
- What medical problems do participants have when taking these supplements?
Researchers will compare three active treatment groups (lavender oil, PEA, Trpti which contains OEA) to a placebo (a look-alike capsule that contains no active ingredients) to see if these natural supplements work to improve sleep and reduce stress.
Participants will take 1 capsule (either active supplement or placebo) every day for 8 weeks and attend 2 clinic visits with a phone check in in between.
Detailed description
The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial This four-arm, parallel-group trial evaluates bioactive compounds targeting stress-sleep pathophysiology (lavender oil, PEA, and OEA). The 8-week intervention employs validated psychometric instruments alongside salivary biomarkers providing objective HPA axis and circadian rhythm assessment. The trial enrolls 240 participants (60 per arm) with moderate stress (PSS ≥14) and sleep complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CPO Lavender oil | Experimental | Dietary Supplement: Lavender Oil85mg CPO Lavender oil will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. |
| Levagen+ PEA | Experimental | Dietary Supplement: Palmitoylethanolamide (PEA)75mg Levagen+ PEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. |
| Trpti OEA | Experimental | Dietary Supplement: Oleoylethanolamide150mg Trpti OEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. |
| Placebo | Placebo comparator | Other: PlaceboA placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Generally healthy adults aged 18 and over.
- Able to provide informed consent.
- Score of at least 14 on the Perceived Stress Scale (PSS).
- Those with a sleep complaint with a frequency of at least 2 times per week(1)
- Agree not to use other dietary supplements for sleep, depression, stress or anxiety other than the investigational product during entire study period.
Key exclusion criteria (14 listed)
- A WHO-5 Well-Being Index score ≤ 28
- Those with severe sleep complaints (Insomnia Severity Index >21)
- Taking prescribed sleep, depression or anxiety medication
- Have a serious illness e.g. asthma, depression, anxiety disorder, bipolar disorder, insomnia, organic sleep disorders (i.e. sleep apnoea), neurological disorders such as MS, kidney disease, liver disease or heart conditions
- Have an unstable illness e.g. diabetes and thyroid gland dysfunction
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 |
|---|---|---|
| Lavender OilAlso: CPO Lavender oil85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days. | Dietary supplement | CPO Lavender oil |
| Palmitoylethanolamide (PEA)Also: Levagen+75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days. | Dietary supplement | Levagen+ PEA |
| OleoylethanolamideAlso: Trpti150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days | Dietary supplement | Trpti OEA |
| PlaceboA placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days. | Other | Placebo |
Primary outcome
Perceived stress via Perceived Stress Scale (PSS)
Time frame: Day 1 to day 57
Change from baseline to the end of the study period in Perceived stress via Perceived Stress Scale (PSS). The Perceived Stress Scale is a self-reported tool for measuring psychological stress. A total PSS-10 score from 0 to 40 is presented, with higher scores representing higher levels of stress.
Anxiety via Beck Anxiety Inventory (BAI)
Time frame: Day 1 to day 57
Change from baseline to the end of the study period in Anxiety via Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report questionnaire evaluating anxiety symptoms, rated on a 4-point scale.
Sleep quality
Time frame: Day 1 to day 57
Change from baseline to the end of the study period in Sleep quality. This will be measured via Pittsburgh Sleep Quality Index (PSQI) and Consensus Sleep Diary. The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns.
15 secondary outcomes
Mental wellbeing
Time frame: Day 1 to day 57
Mood
Time frame: Day 1 to day 57
Sleep duration
Time frame: Day 1 to day 57
Sleep onset latency
Time frame: Day 1 to day 57
Sleep efficiency
Time frame: Day 1 to day 57
Daytime sleepiness
Time frame: Day 1 to day 57
Eating in response to experienced stress
Time frame: Day 1 to day 57
Serotonin
Time frame: Day 1 to day 57
Cortisol
Time frame: Day 1 to day 57
Melatonin
Time frame: Day 1 to day 57
Safety via AE monitoring
Time frame: Day 1 to day 57
Safety via vital signs (blood pressure)
Time frame: Day 1 to day 57
Safety via vital signs (heart rate)
Time frame: Day 1 to day 57
Safety via vital signs (O2 saturation)
Time frame: Day 1 to day 57
Safety via vital signs (temperature)
Time frame: Day 1 to day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
RV Venkatesh study director
Gencor Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lavender Oil, Palmitoylethanolamide (PEA) and Oleoylethanolamide in people with Sleep Disorder (Disorder) and Stress, run by RDC Clinical Pty Ltd at 1 site in Australia.
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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 Australia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Rao, PhD (+61 (0) 7 3102 4486, research@rdcglobal.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress via Perceived Stress Scale (PSS) (time frame: Day 1 to day 57). The study lists 3 primary outcomes in all. 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 23 Apr 2026.