Skeletal Response to Simulated Night Shift

Not Applicable

Recruiting

• Conditions: Osteoporosis; Circadian Rhythm Sleep Disorder, Shift Work Type
• Interventions: Behavioral: Simulated short term night shift work schedule

• Registration Number: NCT05074277
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-12
• Study Start: 2022-02-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simulated Night Shift Work	Simulated short term night shift work schedule	Two inpatient stays, each involving a baseline night, followed by a 3-hour afternoon nap opportunity, and then three 12-hour night shifts, with 8-hour daytime sleep opportunity in between.

Primary Outcome Measures

Name	Time	Method
Difference in change in propeptide of type 1 procollagen (P1NP)	Baseline to day 11	Difference in change in propeptide of type 1 procollagen (P1NP, a bone formation marker) from baseline to day 11 between the control and simulated NSW groups.

Secondary Outcome Measures

Name	Time	Method
Between-group differences in the change in CTX (C-telopeptide of type I collagen)	Baseline to day 11	Between-group differences in the change in bone resorption marker (CTX)
Between-group differences in the change in osteocalcin.	Baseline to day 11	Between-group differences in the change in another bone formation marker (osteocalcin)

Trial Locations

Locations (1)

CU Anschutz; 🇺🇸 Aurora, Colorado, United States