Interview date:
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Today M-D-Y
Thank you for your interest in the SPOTLIGHT study . The purpose of this study is to learn more about how a typical night shift work schedule affects bone health.
Please complete this brief prescreening questionnaire to see if you are eligible. If you are eligible and choose to continue, we will conduct an informed consent meeting, and set up the first in-person study visit (Screening visit) for labs (blood draw and urine drug test), a bone density test, some questionnaires, and a physical exam to confirm you are eligible to participate. If you qualify, you will be randomzied to one of two conditions: control or simulated night shift work. If you join this study, your total participation will last 3-6 weeks. Due to scheduling and nursing availability, your study visits (depicted in the figure and explained below) may not begin for a couple months, however, consent and screening will occur soon after completing this survey.
The intervention includes:
Run-in Week (completed at home) : Study participants will be asked to wear two activity watches, complete a sleep diary, and adhere to an 8 hour/night sleep schedule. The participant will pick up food that will be provided (free of charge) by the University of Colorado nutrition service.
Inpatient Stay # 1 (5 days/4nights) :
Participants randomized to the control arm will maintain their habitual sleep schedule during the inpatient stay. Participants randomized to the simulated night shift work arm will maintain their normal sleep schedule on night 1, and then a "night shift" schedule on days 2-5, which will give them sleep opportunities during the daytime, while staying awake overnight. Participants will discharge on the morning of day 5 and need to be taken home by a friend or family member. Study procedures include: Blood and urine collection Sympathetic nervous system response (your fight or flight system) assessments Questionnaires During your inpatient stays, you will be required to remian at the research facility 24/7 but will be allowed to ambulate around the research facility, work remotely, and have visitors.
Outpatient Measures:
In between inpatient stays, you will be home for 2-4 nights where you will continue wearing the two activity watches, complete a sleep log, and continue eating the controlled diet provided by our nutrition service. If you are in the night shift work group, you will sleep 10 hours on the night you discharge from the inpatient unit and 8 hours per night on subsequent nights. If you are in the control group, you will continue maintaining your habitual sleep schedule.
Inpatient Stay #2 (5 days/4 nights):
The second inpatient stay will be identical to the first inpatient stay.
Outpatient Observation Phase: 3-week observation phase for participants in the night shift work group after discharge from their 2nd inpatient stay.
Participants will be given no instructions on sleep duration or timing. They will complete a sleep diary and continue to wear the two activity watches. Participants will return to the outpatient clinic for fasting blood draws 5 times over a period of 3 weeks and return their sleep diary and one activity watch at the last blood draw. Compensation : Study participants will receive up to $1,500 for completion of the entire study. Study participants will also receive all food (free of charge), labs (free of charge), and the FitBit device used during your study.
Are you interested in participating in this study?
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Yes
No
OK, I understand. Sorry that this study may not work out for you.
Would you be interested in receiving information about our research group and future research studies that you may qualify for?
Yes
No
Great, I will mail or email (whichever you prefer) a one-time newsletter explaining more about our research group and the other research studies that we are conducting.
OK, thank you for your interest in our study.
To see if you qualify for the study, please answer the following eligibility questions, which includes questions about your sleep, and any medical problems you've had in the past. It should take about 10-15 minutes to go through these questions. Some of the questions may make you uncomfortable; you do not have to answer any question that you would not like to answer, but without answers to these questions, you will not be eligible to participate in the study. If you have any questions or concerns, feel free to contact the Colorado Institutional Review Board (COMIRB), the Ethics Board that oversees our research, at (303) 724-1055.
Do you have any questions about the screening questions I will ask you?
Yes
No
Do I have your permission to begin the questions?
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Yes
No
Name:
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Legal full name
Email:
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Cell phone:
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Address:
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Best way to contact you?
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What was your sex assigned at birth?
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Male
Female
What is your gender identity?
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Man
Woman
Non-binary
What pronouns do you prefer (e.g., she/her, he/his, they/them)?
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How old are you?
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What is your date of birth (MM-DD-YYYY)
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Today M-D-Y
How many hours do you sleep on an average night?
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How long does it usually take you to fall asleep?
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What time do you usually go to bed on weekdays?
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Now H:M 24 hour/ Military Time
What time do you usually wake up on weekdays?
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Now H:M
What time do you usually go to bed on weekends?
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Now H:M 24 hour/ Military Time
What time do you usually wake up on weekends?
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Now H:M
Have you performed any night shift work in the last year?
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Yes
No
Have you traveled outside the Mountain Time zone within the last 4 weeks?
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Yes
No
If yes, when were you out of Mountain Time zone?
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The study would require that you be within 1 time zone of Mountain Time Zone for at least 4 weeks prior to the start of the study, is this something you can do?
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Yes
No
Do you exercise?
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Yes
No
If yes, please describe your exercise regimen:
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Do you smoke cigarettes or use tobacco?
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Yes
No
Have you smoked cigarettes or used tobacco within the last year?
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Yes
No
Do you vape or use other nicotine products?
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Yes
No
Do you smoke marijuana?
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Yes
No
If yes, when was the last time you smoked?
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Today M-D-Y
If < 1 month, are you willing to stop smoking marijuana for at least 1 month prior to this study?
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Yes
No
Not Applicable
Do you use recreational drugs?
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Yes
No
If so, describe
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How much do you weigh (in pounds)
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How tall are you (inches)?
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View equation
Are you currently participating in any other research studies?
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Yes
No
If so, what type of research?
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Did the research involve blood draws?
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Yes
No
How much?
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Did the research involve taking medication?
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Yes
No
What medication?
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What is your current occupation?
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Do you have future travel plans that may conflict with participation in this study?
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Yes
No
If so, when, for how many days, and to where?
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Have you lived at Denver altitude for greater than or equal to 1 month?
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Yes
No
How much caffeine do you drink per day (e.g., cups of coffee, soda, chocolate, etc)?
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How much alcohol do you drink per week?
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How much alcohol do you drink per sitting?
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Are you allergic to anything?
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Yes
No
If so, what?
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Are you allergic to Lidocaine (numbing medication)?
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Yes
No
Are you willing/able to travel to/from CU-AMC for study visits?
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Yes
No
Do you have access to a computer to complete study related surveys/receive study-related emails?
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Yes
No
Do you have any dietary restrictions, such as adherence to a vegan diet?
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Yes
No
If so, describe
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Please check all of the following dietary descriptions that apply to you:
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If vegetarian, are you willing to eat eggs every day?
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Yes
No
Have you ever been diagnosed with a medical problem or illness?
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Yes
No
Are you post-menopausal?
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Yes
No
Are you currently pregnant or breast feeding?
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Yes
No
Do you plan on becoming pregnant in the next 6 months?
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Yes
No
Are you currently using any form of birth control?
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Yes
No
If YES, what kind?
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Are you willing to use continuous oral contraception for the entire study (6 weeks)?
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Yes
No
Have you been fully vaccinated against COVID-19, including booster shot if available?
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Yes
In process
No
If yes, when did you complete your vaccination? (You may be required to show proof of COVID vaccination at your Screening visit.)
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Today M-D-Y
If in process, when will you complete your vaccination?
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Today M-D-Y
If no, are you planning to be vaccinated against COVID-19, when?
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You may be required to produce a negative COVID test result before your first in-patient stay.
Cannot be on any medication known to affect bone metabolism, such as glucocorticoids (e.g., prednisone, hydrocortisone, etc) or osteoporosis medications (e.g., alendronate, risedronate, zoledronate, denosumab, teriparatide, abaloparatide) to qualify. Also cannot be on any medications, supplements, etc that impact sleep within the past month to qualify.
Have you ever been diagnosed with a medical problem or illness?
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Yes
No
What medical problem(s) or illness(es) have you been diagnosed with, and when did this occur?
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Have you ever been diagnosed with a psychological or psychiatric problem or illness?
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Yes
No
What psychological or psychiatric problem(s) or illness(es) have you been diagnosed with, and when did this occur?
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Do you have any problems with your sleep?
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Yes
No
If yes, can you describe what problems you have with your sleep?
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Do you have any history of sleep disorder such as night terrors, sleep walking, insomnia, sleep apnea, narcolepsy or periodic limb movements?
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Yes
No
If yes, describe:
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Do you snore?
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Yes
No
Not Sure
Do you use any prescription medication(s)?
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Yes
No
Please provide the name of the medication(s), dose, length of use, and the reason you are using it.
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Have you used any steroids, either oral (e.g., prednisone, hydrocortisone), inhaled (e.g., Flonase, Advair, flovent), or injected (e.g., cortisone) in the last year?
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Yes
No
If yes, please provide the name of any steroids, either oral (e.g., prednisone, hydrocortisone), inhaled (e.g., Flonase, Advair, flovent), or injected (e.g., cortisone) in the last year, the dose, how long you have been using it, and for what purpose.
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Do you use hormones, inhalers, or medicated patches (e.g. nicotine)?
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Yes
No
Please provide the name of the hormone, inhaler, or patch, the dose, how long you have been using it, and for what purpose.
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Do you use any supplements, vitamins, or probiotics?
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Yes
No
Please provide the name of the supplement(s), vitamin(s), or probiotic(s), the dose, how long you have been using it, and for what purpose.
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I am now going to ask you a series of questions about your history of specific medical problems.
Do you have or have you had:
Heart disease or heart problem?
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Yes No
If yes, describe:
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Kidney or liver disease?
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Yes No
If yes, describe:
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Lung disease?
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Yes No
If yes, describe:
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Vision or hearing impairment?
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Yes No
If yes, describe:
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Neurological disease such as stroke, seizure, migraine headache, etc?
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Yes No
If yes, describe:
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Thyroid disease?
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Yes No
If yes, describe:
* must provide value
High blood pressure (aka hypertension)?
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Yes No
If yes, describe:
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Diabetes?
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Yes No
If yes, describe:
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Sedatives (e.g., valium, sleeping pills, anti-anxiety pills)?
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Yes No
If yes, please list the sedative, the dose, how long you have been using it, and for what purpose.
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Antihistamines (e.g. allergy pills)?
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Yes No
If yes, please list the antihistamine, the dose, how long you have been using it, and for what purpose.
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Pain relievers (e.g. aspirin, Tylenol, ibuprofen)?
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Yes No
If yes, please list the pain reliever, the dose, how long you have been using it, and for what purpose.
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Is there anything else that you believe at this time would prevent you from fully participating in this study?
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Yes
No
What?
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Where/how did you learn about this study?
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This is the end of the screening questionnaire. Thank you for your time.
Read one of the appropriate statements below
* You have not met the preliminary screening requirements at this time. We appreciate your interest in our study.
o If you would like us to contact you about future studies for which you may be eligible, you can give me your contact information now and I will send you an authorization form (HIPAA A) to sign and return to us so that we may keep your contact information on file. You may indicate on that form what types of studies you would like to be contacted about (e.g., exercise, weight loss, or hormone replacement studies).
[note: if potential volunteer declines further contact, destroy any PHI written on the phone screening form]
You have met the preliminary screening requirements. The next step in the process is for you to come in and meet with us to review the consent form and to complete an in-person screening visit. Would you like to schedule that now?
Yes
No
Screening/Consent Visit Date:
Today M-D-Y
Screening/Consent Visit Time:
Now H:M
You are asked to fast before you come in for your first study visit because it is required for screening labs. This means you cannot eat anything, or drink anything except for water for 8 hours before your appointment. When you fast, you may feel lightheaded, dizzy, and/or weak.
* Please bring a complete list of all your current medications to the screening visit. The physician will not review these until after you have signed the study consent form.
This is the end of the pre-screen survey. Thank you for your time. We will be in touch.