Sleep and stress relief with lavender, PEA, or OEA supplements
The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial
This trial will test whether a daily capsule of lavender oil, PEA, or OEA helps adults with moderate stress who have sleep problems sleep better and feel less stressed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RDC Clinical Pty Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brisbane) |
| Trial ID | NCT07315516 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 2 trial will enroll 240 adults with moderate perceived stress (PSS ≥14) and regular sleep complaints and randomize them to one of four daily capsules (lavender oil, PEA, OEA, or placebo) for 8 weeks. Outcomes include validated sleep and stress questionnaires plus salivary biomarkers of HPA axis activity and circadian rhythm, with two clinic visits and one phone check-in. The study excludes people with severe insomnia or very low well-being and asks participants to avoid other sleep or stress supplements and not change diet or exercise during the study. Safety and adverse events will be monitored throughout to characterize tolerability.
Who should consider this trial
Good fit: Adults aged 18 and over who are generally healthy, have a PSS score of at least 14, and report sleep complaints at least twice per week are the intended participants.
Not a fit: People with severe insomnia (Insomnia Severity Index >21), very low well-being (WHO-5 ≤28), or those already using other sleep/stress supplements are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these natural supplements could provide a readily available option to improve sleep quality and reduce stress and anxiety symptoms.
How similar studies have performed: Smaller trials and clinical reports suggest lavender can modestly improve sleep and anxiety, whereas evidence for PEA and OEA in sleep is limited, so this combination builds on mixed early evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 1. 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.) Exclusion Criteria: * 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 * 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
Where this trial is running
Brisbane
- RDC Clinical — Brisbane, Australia (Recruiting)
Study contacts
- Study coordinator: Amanda Rao, PhD
- Email: research@rdcglobal.com.au
- Phone: +61 (0) 7 3102 4486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.