Sleep and Stress Study

RDC Clinical

Status and phase: Not yet enrolling; Phase 2

Conditions: Sleep Disorder (Disorder); Anxiety; Stress

Treatments: Other: Placebo; Dietary Supplement: Lavender Oil; Dietary Supplement: Palmitoylethanolamide (PEA); Dietary Supplement: Oleoylethanolamide

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07315516

EVESLE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups, including a placebo group

CPO Lavender oil

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lavender Oil

Levagen+ PEA

Experimental group

Description:

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

Treatment:

Dietary Supplement: Palmitoylethanolamide (PEA)

Trpti OEA

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oleoylethanolamide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo