Sleep problems related to shift work Shift work sleep disorder Sleep quality CBD-Hemp Oil Cannabidiol Sublingual supplement Shift work Sleep quality Sleep disorder PSQI Sleep tracker Heart rate variability Randomized controlled trial Placebo MCT oil
Conditions
Interventions
Participants in the experimental arm will receive CBD Hemp Oil as a sublingual health supplement. The product contains cannabidiol from hemp in MCT oil. Participants will administer 5 drops equal to 0
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
CBD Hemp Oil,Placebo MCT Oil
Sponsors
Suan Sunandha Rajabhat University
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male participants aged 20 to 60 years. 2. Currently working in rotating shifts or night shifts for at least 3 months prior to enrollment. 3. Having shift work-related sleep disturbance, defined by poor sleep quality according to the study screening criteria, such as PSQI score > 5. 4. Generally healthy based on medical history and screening assessment. 5. Able to understand the study procedures and provide written informed consent. 6. Willing to comply with the study protocol, including use of the wearable device and completion of sleep questionnaires.
Exclusion criteria
Exclusion criteria: 1. History of severe psychiatric, neurological, cardiovascular, hepatic, renal, or respiratory disease. 2. Diagnosed sleep disorders not related to shift work, such as obstructive sleep apnea, narcolepsy, or restless legs syndrome. 3. Current use of sleeping pills, sedative drugs, antidepressants, antipsychotics, melatonin, cannabis products, or other products that may affect sleep within 2 weeks prior to enrollment. 4. Known allergy or hypersensitivity to CBD-Hemp oil, MCT oil, or any component of the study product. 5. History of alcohol or substance abuse. 6. Abnormal liver or renal function tests considered clinically significant by the investigator. 7. Participation in another clinical trial within 30 days prior to enrollment. 8. Inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality Baseline, week 1, week 4, and week 8 Pittsburgh Sleep Quality Index (PSQI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep efficiency (%) Baseline 7-night monitoring period and weekly 7-night averages throughout the 8-week intervention. Average sleep efficiency (%) measured by Xiaomi Smart Band 10 via Mi Fitness. Defined as total sleep time divided by time in bed x 100. | — |
Countries
Thailand
Contacts
Public ContactWaisith Boontheppratan
Suan Sunandha Rajabhat University
Outcome results
None listed