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Recruiting NCT07315516

Sleep and Stress Study

Phase II Interventional Sleep Disorder (Disorder) Stress Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lavender Oil, Palmitoylethanolamide (PEA), Oleoylethanolamide, Placebo.
Who it may be relevant to
Registry conditions: Sleep Disorder (Disorder), Stress, Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial

Overview

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.

Interventions

  • Dietary supplement Lavender Oil
    85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
  • Dietary supplement Palmitoylethanolamide (PEA)
    75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
  • Dietary supplement Oleoylethanolamide
    150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days
  • Other Placebo
    A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.

Primary outcome measures

  • Perceived stress via Perceived Stress Scale (PSS) [Time frame: Day 1 to day 57]
  • Anxiety via Beck Anxiety Inventory (BAI) [Time frame: Day 1 to day 57]
  • Sleep quality [Time frame: Day 1 to day 57]
Secondary outcome measures (12)
  • 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]

Eligibility 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.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • RDC Clinical — Brisbane

Identifiers

NCT: NCT07315516 · EVESLE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗