OsteoporosisSPOTLIGHTNCT05074277
Skeletal Response to Simulated Night Shift
A study testing Simulated short term night shift work schedule in people with Osteoporosis and Circadian Rhythm Sleep Disorder, Shift Work Type, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Circadian Rhythm Sleep Disorder, Shift Work Type
- What is being tested?
- Simulated short term night shift work schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 30Show fewer
- 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 disorders or significant head injury) or any history of seizure (including febrile seizure-sleep loss has been used clinically to induce seizures in patients with epilepsy). Given the wide range of illnesses that are encountered in medical practice, it would not be possible to provide a comprehensive list of each and every disease that could serve as grounds for exclusion for the subject. However, the following is a list of illness categories that would certainly be grounds for exclusion: Connective Tissue and Joint Disorders; Neurologic/cognitive Disorders; Musculoskeletal Disorders; Immune Disorders; Chronobiologic Disorders; Cardiovascular Disorders; Respiratory Disorders; Kidney Disorders; Infectious Diseases; Hematopoietic Disorders; Neoplastic Diseases; and Endocrine and Metabolic Diseases.
- 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
- Any clinically significant psychiatric condition, as defined by DSM-V. Individuals with a history of most psychiatric illnesses or psychiatric disorders will be excluded, such as but not limited to depression, anxiety, alcoholism, drug dependency, schizophrenic disorders, and personality disorders (performed by medical history and physician interview). However, a personal history of limited prior counseling, psychotherapy (e.g., for adjustment reactions) will NOT be exclusionary.
- Evaluation of Psychiatric/Psychological Suitability:
- Inability to demonstrate a full understanding of the requirements and demands of the study.
- Each participant will complete psychological screening questionnaires. Exclusionary: Center for Epidemiological Studies Depression (CES-D) > 16. Subject responses to the CES-D are reviewed immediately and appropriate referrals are made if necessary.
- 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.
- Use of anti-depressants or any like therapeutics prescribed by a physician is exclusionary
- 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);
- Use of medications/supplements/drugs that impact sleep or bone metabolism (such as but not limited to sleep medications, marijuana, etc.) within one month (participants can be studied at a later date).
- Dwelling below Denver altitude (1,600 m) 1 month prior to enrollment.
- Greater than moderate caffeine (>500 mg/day) or alcohol use (>14 standard drinks/ week or >5 drinks in one sitting)
- Inability to travel to the CU-AMC campus for study visits.
- Individuals with restrictive diets (e.g., vegan)
- Individuals with 25OHD < 20 ng/mL (may be studied at a later date)
- Individuals with eGFR < 60 mL/min/1.73m2 as this is known to affect CTX measurements.
- Z-score < -2.0 for bone mineral density at the L-spine, femoral neck, or total hip on baseline DXA as compared to the DXA machine's normative database.
- Symptoms of active illness (e.g., fever) at time of enrollment; note - participant may be studied at a later date.
- Restrictive diets that cannot be accommodated by the CTRC Nutrition Core
- Any other reason that participant may not be able to safely complete the entire study, at PI discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)
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.
- Being tested
- Simulated short term night shift work schedule
- Medical subject headings
- Osteoporosis, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated short term night shift work scheduleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Simulated short term night shift work schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to day 11
Secondary outcomes (2)
Between-group differences in the change in osteocalcin.
Between-group differences in the change in another bone formation marker (osteocalcin)
Measured: Baseline to day 11
Between-group differences in the change in CTX (C-telopeptide of type I collagen)
Between-group differences in the change in bone resorption marker (CTX)
Measured: Baseline to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start8 Feb 2022
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christine M Swanson, MD, MCR, Principal investigator, CU Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074277
- Sponsor's protocol ID
- 20-3013
- Other IDs
- R01HL151332
- Acronym
- SPOTLIGHT
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)
- ClinicalTrials.gov ID
- NCT05074277
- Acronym / sponsor ID
- SPOTLIGHT / 20-3013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (8 hours nocturnal sleep) | No intervention | –Inpatient protocol involves 8-hour sleep opportunity during the biological night throughout. |
| Simulated Night Shift Work | Experimental | Behavioral: Simulated short term night shift work scheduleTwo 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated short term night shift work scheduleParticipant 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. | Behavioural | Simulated Night Shift Work |
Primary outcome
Difference in change in propeptide of type 1 procollagen (P1NP)
Time frame: 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.
2 secondary outcomes
Between-group differences in the change in osteocalcin.
Time frame: Baseline to day 11
Between-group differences in the change in CTX (C-telopeptide of type I collagen)
Time frame: Baseline to day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine M Swanson, MD, MCR principal investigator
CU Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated short term night shift work schedule in people with Osteoporosis and Circadian Rhythm Sleep Disorder, Shift Work Type, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in propeptide of type 1 procollagen (P1NP) (time frame: Baseline to day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.