Last updated: November 23, 2023
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Sleep Disorders
Narcolepsy
Treatment
Sleep Intervention
Nutritional intervention
Clinical Study ID
NCT06147089
MEC-82649
NL82649.078.22
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18 to 60 years.
- Work at least 4 night shifts a month on average.
- Shift workers, working rotating shifts (morning, evening and night shifts) or workingpredominantly night shifts. Night shift defined as work at least 1 hours between 0:00-and 6:00.
- Work at least 2 night shifts in a row
- Work ≥ 20 work hours per week.
- Having a shift duration of 6 h-12 h.
- History of ≥ 1 year of working rotating shift work or night shifts prior to the study.
Exclusion
Exclusion Criteria:
- Taking medication that the investigator believes would interfere with the objectivesof the study. For example, sleep medication, medication that interferes with glucosehomeostasis, and/or anti-inflammatory drugs.
- Pregnant or have a wish to become pregnant during the study period.
- Planned surgery during the entire study period Alcohol consumption > 21 units/week
- Severe psychiatric disease and/or any mental or physical disability that will hinderparticipation in the interventions
- Severe cardiovascular disease, to the discretion of the study doctor
- Having a chronic inflammatory disease, including asthma, rheumatic fever, irritablebowel disease, chronic obstructive pulmonary disease.
- Other bowel diseases, including Chron's disease and Colitis Ulcerosa.
- A disease or condition with higher bleeding risk (/risk of hemorrhage), under which ablood sample may lead to complications.
- Participation in any clinical trial including blood sampling and/or administration ofsubstances up to 90 days before Day 01 of this study
- Recent blood donation (<1 month prior to the start of the study)
Study Design
Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Sleep Intervention
Phase:
Study Start date:
February 09, 2023
Estimated Completion Date:
June 01, 2026
Study Description
Connect with a study center
Erasmus MC
Rotterdam,
NetherlandsActive - Recruiting
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