Skeletal Response to Simulated Night Shift (NCT05074277) | Clinical Trial Compass
CompletedNot Applicable
Skeletal Response to Simulated Night Shift
United States20 participantsStarted 2022-02-08
Plain-language summary
This small intervention study will determine if simulated short-term night shift work (NSW) negatively alters bone metabolism. The specific aim of the study is to determine if NSW acutely uncouples bone turnover markers (BTMs), if sympathetic tone is a mechanism for this disruption and if a resumption of a normal sleep/wake pattern reverses BTM uncoupling. Our hypothesis is that NSW will reversibly uncouple BTMs via increased sympathetic nervous system (SNS) tone.
Who can participate
Age range20 Years – 40 Years
SexALL
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Inclusion Criteria
* Healthy, nonpregnant adults 20-40 years old who habitually sleep 7-9 hours during the biological night
o Women must be premenopausal, on continuous combination oral contraception and not breastfeeding.
* Willing and able to complete a sleep diary, wear a wrist actigraphy monitor and complete a 3-6 week research study including two 4-night inpatient stays.
* Fully vaccinated against SARS-CoV-2, and willing to produce a negative COVID test result before their first inpatient stay.
Exclusion Criteria
* Regularly go to sleep after midnight.
* Night shift work within 1 year prior to study.
* Travel \> 1 time zone within 4 weeks prior to the study or need to travel \>1 time zone during study.
* Physical activity level/regimen incompatible with inpatient CTRC stay.
* Current smokers (or within the previous year of study)
* Positive drug test at screening or inpatient admission
* BMI \> 30 kg/m2
* 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 disorde…
What they're measuring
1
Difference in change in propeptide of type 1 procollagen (P1NP)