← Back to Search

Simulated Night Shift for Circadian Rhythm Disorder (SPOTLIGHT Trial)

N/A
Recruiting
Led By Christine M Swanson, MD, Phd
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must be premenopausal, on continuous combination oral contraception and not breastfeeding
Healthy, nonpregnant adults 20-40 years old who habitually sleep 7-9 hours during the biological night
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 11
Awards & highlights

SPOTLIGHT Trial Summary

This trial will study the effects of night shift work on bone metabolism, specifically if it causes bone turnover markers to become uncoupled, and if this is due to increased sympathetic nervous system activity.

Who is the study for?
Healthy adults aged 20-40, who sleep 7-9 hours at night and are fully vaccinated against COVID-19. Women must be premenopausal, on oral contraception, not breastfeeding. Participants should commit to a study including inpatient stays and wear a wrist monitor for activity tracking.Check my eligibility
What is being tested?
The trial is testing how simulated night shift work affects bone metabolism by measuring bone turnover markers and sympathetic nervous system tone. It involves two sets of four-night inpatient stays with follow-up to see if normal patterns reverse any changes.See study design
What are the potential side effects?
There may not be direct side effects from the intervention as it's a lifestyle simulation rather than medication; however, participants might experience fatigue or stress due to altered sleep patterns.

SPOTLIGHT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a premenopausal woman not breastfeeding and on birth control pills.
Select...
I am a healthy adult, aged 20-40, not pregnant, and I usually sleep 7-9 hours at night.
Select...
I am a healthy adult, aged 20-40, who sleeps 7-9 hours at night and am not pregnant.

SPOTLIGHT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in change in propeptide of type 1 procollagen (P1NP)
Secondary outcome measures
Between-group differences in the change in CTX (C-telopeptide of type I collagen)
Between-group differences in the change in osteocalcin.

SPOTLIGHT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Simulated Night Shift WorkExperimental Treatment1 Intervention
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.
Group II: Control (8 hours nocturnal sleep)Active Control1 Intervention
Inpatient protocol involves 8-hour sleep opportunity during the biological night throughout.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,358 Total Patients Enrolled
11 Trials studying Osteoporosis
1,212 Patients Enrolled for Osteoporosis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,417 Total Patients Enrolled
10 Trials studying Osteoporosis
2,913 Patients Enrolled for Osteoporosis
Christine M Swanson, MD, PhdPrincipal InvestigatorCU Anschutz

Media Library

Simulated short term night shift work Clinical Trial Eligibility Overview. Trial Name: NCT05074277 — N/A
Osteoporosis Research Study Groups: Control (8 hours nocturnal sleep), Simulated Night Shift Work
Osteoporosis Clinical Trial 2023: Simulated short term night shift work Highlights & Side Effects. Trial Name: NCT05074277 — N/A
Simulated short term night shift work 2023 Treatment Timeline for Medical Study. Trial Name: NCT05074277 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for participation in this medical experiment inclusive of patients older than 70?

"According to the research protocol, only individuals between 20 and 40 years old are eligible for this trial."

Answered by AI

Are there currently any enrolment opportunities for this experiment?

"As detailed on clinicaltrials.gov, the study is actively searching for participants to join their trial that was posted on February 8th 2022 and amended most recently November 1st of the same year."

Answered by AI

What is the current capacity of this experiment?

"Affirmative. Clinicaltrials.gov hosts records that confirm this trial, which was first publicized on February 8th 2022, is actively enrolling interested parties. As of now, only 20 patients need to be enrolled from one single medical centre."

Answered by AI

What are the eligibility criteria for participation in this research?

"The requirements for this medical trial is that candidates should be between 20 and 40 years old, and possess bone resorption. A total of 20 individuals will qualify to take part in the study."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
CU Anschutz
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Jul 2024