Sleep and Stress Study

NCT07315516 | Recruiting Phase 2

• 1 other identifier: EVESLE
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Disorder (Disorder); Stress; Anxiety

Keywords

Sleep complaints

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Day 1 to day 57

Secondary Outcomes (15)

• Mental wellbeing

  Day 1 to day 57

• Mood

  Day 1 to day 57

• Sleep duration

  Day 1 to day 57

• Sleep onset latency

  Day 1 to day 57

• Sleep efficiency

  Day 1 to day 57

Study Arms (4)

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.

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.

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.

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.

Other: Placebo

Interventions

Placebo OTHER

A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.

Placebo

Lavender Oil DIETARY_SUPPLEMENT

85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.

Also known as: CPO Lavender oil

CPO Lavender oil

Palmitoylethanolamide (PEA) DIETARY_SUPPLEMENT

75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.

Also known as: Levagen+

Levagen+ PEA

Oleoylethanolamide DIETARY_SUPPLEMENT

150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days

Also known as: Trpti

Trpti OEA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Gencor Pacific Limited, Hong Kong: collaborator

Study Sites (1)

RDC Clinical

Brisbane, Australia

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Anxiety Disorders

Interventions

lavender oil; palmidrol; oleoylethanolamide

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• RV Venkatesh

  Gencor Pacific

  STUDY DIRECTOR

Central Study Contacts

Amanda Rao, PhD

CONTACT

+61 (0) 7 3102 4486; research@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-12

Locations

AU (1)