Sleep and Stress Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRDC Clinical Pty Ltd
About this 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:
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lavender Oil
Dietary supplement85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Palmitoylethanolamide (PEA)
Dietary supplement75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
Oleoylethanolamide
Dietary supplement150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days
Placebo
Other interventionA placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: CPO Lavender oilExperimental treatment 1 intervention
Group B: Levagen+ PEAExperimental treatment 1 intervention
Group C: Trpti OEAExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1 to day 572
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.
Time frame
Day 1 to day 573
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.
Time frame
Day 1 to day 57Secondary outcomes
1
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.
Time frame
Day 1 to day 572
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.
Time frame
Day 1 to day 573
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.
Time frame
Day 1 to day 574
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.
Time frame
Day 1 to day 57Sponsors and contacts
Click on the lead sponsor to view all of their trials.
RDC Clinical Pty Ltd
Lead sponsor
Gencor Pacific Limited, Hong Kong
Collaborator
Source ClinicalTrials.gov