Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study.

Phase 4

Completed

• Conditions: Sleep disturbance; Neurological - Other neurological disorders

• Registration Number: ACTRN12618001339246
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-09
• Study Completion: 2020-09-25
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Male and females over 18 years old
Disturbed sleeping pattern
Generally healthy
Able to provide informed consent
Females on a prescribed form of birth control
Agree not to change current diet/exercise or not to use other dietary supplements other than the test product during entire study period.

Exclusion Criteria

Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)
Regular sleeping pattern
Malignancy or treatment for malignancy within the previous 2 years
Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
Receiving/prescribed sleep medication/aid
Sleep apnea
Diagnosed or consistent gastrointestinal issues that disrupt sleep
Active smokers, nicotine, alcohol, drug abuse
Chronic past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients in active or placebo formula
People with serious mood disorders (such as depression and bipolar disorder) will be excluded. The Depression, Anxiety, Stress scale could be used as a screening form to ensure that those with undiagnosed depression are not enrolled into the study
Those suffering from insomnia or have night-shift employment and unable to have a normal night’s sleep
People suffering any neurological disorders such as MS
Pregnant or lactating woman
Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Participants who have participated in any other related clinical trial during the past 1 month
Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
History of infection in the month prior to the study
Regularly taking stimulants (e.g. coffee, caffeine supplements, caffeine containing beverages) from midday onwards
Disturbed sleeping pattern caused by external factors (e.g. children, partner, noises)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality measured by Pittsburgh sleep quality survey [Baseline, day 5, weeks 2, 4, 8 and 10 (primary endpoint) post start of intervention ];Sleep quantity measured by Pittsburgh sleep quality survey[Baseline, day 5, weeks 2, 4, 8 and 10 (primary endpoint) post start of intervention ]