Skeletal Response to Simulated Night Shift

NCT05074277 | Completed

• 2 other identifiers: 20-3013R01HL151332
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Circadian Rhythm Sleep Disorder, Shift Work Type

Outcome Measures

Primary Outcomes (1)

• Difference in change in propeptide of type 1 procollagen (P1NP)

  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.

  Baseline to day 11

Secondary Outcomes (2)

• Between-group differences in the change in osteocalcin.

  Baseline to day 11

• Between-group differences in the change in CTX (C-telopeptide of type I collagen)

  Baseline to day 11

Study Arms (2)

Control (8 hours nocturnal sleep)

NO INTERVENTION

Inpatient protocol involves 8-hour sleep opportunity during the biological night throughout.

Simulated Night Shift Work

EXPERIMENTAL

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.

Behavioral: Simulated short term night shift work schedule

Interventions

Simulated short term night shift work schedule BEHAVIORAL

Participant sleep schedules (in the experimental arm) will be modified to simulate short-term (3 consecutive nights) night shift work schedule (kept awake at night and offered sleep opportunities during the day instead) in each of two inpatient stays.

Simulated Night Shift Work

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Self-reported or newly diagnosed medical condition that is still being investigated or is not under good control, including those identified on screening labs such as:
• o Out-of-range values measured on a fasting blood sample: glucose \> 100 mg/dl, thyroid stimulating hormone \<0.5 or \>5.0 uU/ml, abnormal alkaline phosphatase \<39 or \>117 U/l, creatinine, or hemoglobin \<14.5 g/dl men
• Evaluation of Psychiatric/Psychological Suitability:
• Inability to demonstrate a full understanding of the requirements and demands of the study.
• Individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressants, neuroleptic medications or major tranquilizers will be excluded from study.
• Individuals with any clinically significant sleep disorder; Diagnosis or symptoms of sleep disorders (history of significant parasomnia as an adult \[night terrors, frequent sleep walking\], insomnia, including but not limited to hypersomnias such as apnea, periodic limb movements, narcolepsy). Sleep disorders will be screened by self-report and physician interview including use of validated sleep questionnaires (PSQI, Epworth sleepiness scale, and Berlin sleep questionnaire for sleep apnea). The following scores will be used to exclude those with sleep disorders: PSQI \>5, Epworth Sleepiness Scale \>9.
• Individuals on medications known to affect bone turnover (e.g., glucocorticoids, osteoporosis medications);

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

CU Anschutz

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Osteoporosis; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Christine M Swanson, MD, MCR

  CU Anschutz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: February 8, 2022
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)