Skeletal Effects of Chronic Night Shift (NCT05091021) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Skeletal Effects of Chronic Night Shift
United States40 participantsStarted 2021-10-27
Plain-language summary
The specific aim of this observational study is to characterize changes in bone turnover makers (BTMs), bone mineral density (BMD), and bone microarchitecture in a cohort of nurses during their first year of night compared to day shift work. The hypothesis is that night shift nurses will have poorer bone health indices at one year compared to day shift nurses.
Who can participate
Age range20 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Healthy, nonpregnant adults 20-50 years old who recently (≤6 months) graduated from nursing school and were hired by University of Colorado Hospital for their first nursing position
* For women to be eligible, they must be premenopausal, not breastfeeding, not pregnant with no plans to become pregnant during the year of observation and willing/able to maintain their current method of contraception use as detailed below.
* Willing and able to travel to/from CU-AMC for study measurements at baseline and quarterly for one full year
Exclusion Criteria
* Non-nursing school related shift work 1 year prior to study. (note: many nursing students work as an Advanced Care Partner (ACP) or as a Student Nurse Extern (SNE) and these positions will not be considered exclusionary).
* Current smokers at baseline (or within the previous year of study).
* Individuals who are concurrently participating in another research protocol that would influence their safe participation in this study. For example, participants involved in a study that requires blood draws or ingestion of experimental medication as this would increase the risk of participation in our study and/or compromise study results.
* Any clinically significant unstable medical or surgical condition within the last year (treated or untreated), including history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure…
What they're measuring
1
Difference in change of propeptide of type 1 procollagen (P1NP) over 1 year