Principal Investigator: Christopher M. Depner, Ph.D. Date: 8/19/2020 This study is conducted by the Sleep and Chronobiology Laboratory at the University of Colorado Boulder. RADS Sleep Study Requirements: Healthy Men & Women Age 18-35 who sleep less than 6.5 hours per night
This study is broken down into 8 in-person visits to the Sleep and Chronobiology Laboratory on the University of Colorado Boulder Campus. During the study, you will live in the Sleep and Chronobiology Laboratory for approximately 20 hours (including wakefulness and sleep) on two separate in-lab visits (study visits #5 and #8). The other 6 visits to the laboratory will consist of screening tests (including COVID-19) to determine if you qualify for the study or instructional and informational meetings with the research staff. We will schedule your study so the visits where you live in the Sleep and Chronobiology Laboratory fit your personal schedule and availability. Because of this scheduling, we anticipate the entire study will take you approximately 2-3 months to complete.
Before starting this study, there are screening procedures to ensure you meet the study criteria. If you meet the study criteria, we will schedule you for an informed consent appointment (study visit #1) where you will learn more about the study and answer questionnaires. Your next study appointment (study visit #2) will be a medical screening appointment where you will have a physical exam, blood work, drug screen, pregnancy test, and electrocardiogram (a measurement of heart activity). All of the results of the screening procedures are confidential and will only be used by the study staff to determine eligibility for the study.
Following the screening procedures in study visits #1 and #2, you will complete two overnight in-lab visits. The first overnight in-lab visit will be preceded by two weeks of home sleep monitoring and the second overnight in-lab visit will be preceded by four weeks of home sleep monitoring. During your home monitoring, we ask you to wear a special watch (actiwatch) that records activity and light levels. We also ask you to keep paper and electronic sleep diaries. For study visit #3 you come to the Sleep and Chronobiology Laboratory to pick-up your actiwatch and get instructions for the sleep diaries for the two weeks of home sleep monitoring before your first overnight in-lab visit. During the first overnight in-lab visit (study visit #5) you will sleep and wake at your habitual sleep/wake times.
Following study visit #5 we will instruct you to increase your nightly time in bed by 2 hours for the next four weeks of home sleep monitoring. At the mid-point of these four weeks of home monitoring you will be asked to come to the Sleep and Chronobiology Laboratory (study visit #6) to review your actiwatch and sleep schedule with research staff. During the second overnight in-lab visit (study visit #8) we will change your sleep schedule to meet the recommended 7 or more hours of sleep per night. While you are awake during the overnight in-lab visits, we will ask you to perform several computer tasks measuring your ability to think. We will also collect blood and saliva samples to test for small molecules and hormones.
If you are eligible to participate in this study, you will be financially compensated for your involvement after the screening procedures. You will be compensated $75 per week for the two weeks of home activity monitoring before your first overnight in-lab visit, $100 per week for the four weeks of home activity monitoring before your second overnight in-lab visit, and $175 per overnight in-lab visit for both of your overnight in-lab visits. The total compensation can be up to $1000.
If you are interested in applying to participate in this study, please complete this on-line survey. We will contact you within one week to let you know if you qualify for the first consent screening appointment. If you need assistance with this survey, have additional questions about the study, or would like to complete the survey via the telephone, please contact the Sleep and Chronobiology Laboratory at (303) 735-1923 (M-F, 9am-5pm).
Checking "I agree" documents that you have read the information about the study and give your permission to take part in the initial screening for this research.
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What is today's date?
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Today D-M-Y
What is your full name?
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What is your sex?
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Male
Female
What is your current address?
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What is your phone number?
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What is your email address?
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How old are you?
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What is your date of birth?
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Today D-M-Y
How tall are you (feet, inches)?
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How much do you weigh (in pounds)?
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Have you had a weight change in the past six months?
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No
If yes, how many pounds, was it a loss or gain, was it due to a weight loss/gain program, and what is your future weight goal?
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What is the most that you have weighed in your lifetime, excluding pregnancy (in pounds)?
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Do you exercise regularly?
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How many times a week and for what duration (e.g. 45 minutes) do you exercise?
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What type of exercise do you do?
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Which is your dominant hand?
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Left
Right
Both
What is your current occupation?
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What month(s) would you be available to spend ~2 days, 28 days apart, in our sleep laboratory for the study?
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Have you ever participated in a research study?
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What type of research study did you participate in?
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When did you participate in a research study?
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Did the research study involve blood draws? If so, how much blood did you donate?
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Did the research study involve taking medication? If so, please list the name of the medication.
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Have you ever been diagnosed with a medical problem or illness?
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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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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 currently use any prescription medication?
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Please provide the name of the medication(s), dose, length of use, and the reason you are using it.
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Do you currently use hormones (e.g. contraceptive birth control), inhalers, or medicated patches (e.g. nicotine)?
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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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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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Next is a series of questions about your medical history. Please indicate if you have now or have ever had any of the following conditions. If your response is "Yes" to a question, please explain when the problem was identified or diagnosed, what treatment you use(d) for it and when, and whether you experienced any complications from it.
Have you ever had or do you currently have heart disease or a heart murmur?
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What heart disease(s) or murmurs have you had? When were they identified? If they are treated, how? Have you had any complications from this?
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Have you ever had or do you currently have any type of lung disease?
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What lung disease(s) have you had? When were they identified? If they are treated, how? Have you had any complications from this?
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Have you ever had or do you currently have any type of kidney disease?
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No
What kidney disease(s) have you had? When were they identified? If they are treated, how? Have you had any complications from this?
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Have you ever had any type of stomach or intestine disease [e.g. ulcers, acid reflux, Irritable Bowel Syndrome (IBS)]?
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No
What stomach disease have you had? When were they identified? If they are treated, how? Have you had any complications from this?
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Have you ever had and do you currently have any type of visual impairment?
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No
What type of visual impairment did you have or do you currently have?
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Have you received corrective eye surgery (e.g. Lasik) for your vision impairment?
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Do you wear contact lenses or glasses?
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No
What type of corrective lenses do you use?
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Primarily contact lenses
Primarily eyeglasses
Both contact lenses and eyeglasses
Have you had any eye injuries?
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What type of eye injury have you had? When did this occur? If it was treated, how? Have you had any complications from this?
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Are you colorblind?
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I don't know
What type of colorblindness do you have?
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Do you have any hearing impairment?
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What type of hearing impairment do you have?
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Have you ever had any type of neurological disease (e.g. stroke, seizures, migraine headaches)?
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No
What type of neurological disease have you had? When was it identified? If it is treated, how? Have you had any complications from this?
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Have you ever been diagnosed with peripheral neuropathy associated with cold intolerance, numbness and skin color changes in the hands, complex regional pain syndrome (CRPS), Raynaud phenomenon, occlusive vascular disease of the hand, acrocyanosis, erythromelalgia, or metabolic or autoimmune diseases that affect blood flow in your hands or feet?
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Yes
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If yes, what condition were you diagnosed with? When was it identified? If it is treated, how? Have you had any complications from this?
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Have you experienced accidents, head injuries, concussions, or loss of consciousness?
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No
What was the nature of your accident, head injury, or concussion? What length of time did you lose consciousness for, if at all? When did the incident occur, what (if any) treatment have you undergone for it, and have you experienced any long term complications because of it?
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Have you ever had or do you currently have thyroid disease (e.g. hyper or hypothyroidism)?
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No
What type of thyroid disease have you had? When was it identified? If it is treated, how?
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Have you had or do you have high blood pressure?
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When was it identified? If it is treated, how?
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Do you have diabetes?
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Yes
No
What type of diabetes have you had? When was it identified? If it is treated, how?
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Do you have hepatitis?
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When were you diagnosed? What doctor recommendations have you received?
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What type of hepatitis do you have?
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Have you ever had or do you now have asthma?
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Has your asthma been influenced by age, physical activity, or temperature? How do you manage or treat it?
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Have you ever had surgery?
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No
What type of surgery? When? Was local or general anesthesia used? Did you have any complications following the surgery?
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What type of caffeine do you typically consume? (check all that apply)
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How much coffee do you drink and how often? Please specify the size of the drink (e.g. 8 oz.), and the number you consume per day, week, or month.
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How much caffeinated tea do you drink and how often? Please specify the size of the drink (e.g. 8 oz.) and the number you consume per day, week, or month.
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How many caffeinated soft drinks do you consume, and how often? Please specify the size of the drink (e.g. one 12 ounce can or one 20 ounce bottle) and how many you consume per day, week, or month.
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Please specify the energy drink you use, the size, and how many you consume per day, week, or month.
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How much chocolate do you eat and how often?
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Please indicate if you use the following: (check all that apply)
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What antihistamines do you use, what dose, how frequently, and for what purpose?
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What type of pain reliever do you use, what dose, how frequently, and for what purpose?
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What type of antacid do you use, how frequently, and for what purpose?
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Do you drink alcohol?
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Yes
No
On average, how many days per week do you drink alcohol, and how much do you drink on each occasion?
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Do you ever use tobacco?
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What type of tobacco do you use? (check all that apply)
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How long have you chewed tobacco, how much, and how often do you chew?
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How long have you smoked cigarettes, how many cigarettes do you smoke per day, and have you ever quit smoking (if yes, provide details like when and for how long you stopped)?
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How long have you smoked cigars, pipe tobacco, or hookah and how much do you smoke per day?
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Do you ever use Marijuana?
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Yes No
On average, how many times per week do you use Marijuana?
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Do you have any problems with your sleep?
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Yes No
What type of problems do you have with your sleep?
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How long does it usually take you to fall asleep?
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How many hours do you sleep in an average night?
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What is your usual bedtime on weekdays?
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Now H:M
What is your usual wake time on weekdays?
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Now H:M
What is your usual bedtime on weekends?
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Now H:M
What is your usual wake time on weekends?
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Now H:M
Have you traveled outside the mountain time zone within the past 3 months?
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Yes No
Where did you go, for how many days, and what date did you return?
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Do you have future travel plans that may conflict with participation in this study; if so, when, for how many days, and to where?
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Have you ever worked the night shift?
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Yes No
What hours did you work on the night shift?
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How many days per week did you work the night shift?
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How long (months or years) did you work night shifts?
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What month and year did you stop doing night shift work?
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As of today, how long have you lived at the altitude of Denver or higher?
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Where did you live previously and for how long?
Do you use hormonal contraceptives?
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Yes No
What type of hormonal contraceptive do you use?
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How long have you been using this hormonal contraceptive?
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How many days are there from the start of one menstrual period to the start of the next menstrual period for you?
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What was the start date of your last menstrual cycle?
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Today D-M-Y
What was the start date of your menstrual cycle prior to that (e.g. your second-to-last menstrual cycle)?
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Today D-M-Y
Is the number of days between your menstrual period consistent from month to month?
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Yes No
Please explain how the length of time between your menstrual periods varies from month to month.
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Have you given birth in the past year?
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Yes No
Are you currently breastfeeding?
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Yes No
Please check all of the following dietary descriptions that apply to you:
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How long have you been vegetarian?
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How long have you been vegan?
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Please describe your gluten sensitivity or allergy, including how long you have experienced this and how you modify your diet.
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Please describe your dairy sensitivity or allergy, including how long you have experienced this and how you modify your diet.
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Please describe your other food sensitivity, allergy or restriction, including how long you have experienced this and how you modify your diet.
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How did you hear about our study?
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If online or newspaper advertisement, what was the website or newspaper?
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I give permission for my information to be included in the study collaborator's recruitment database to take part in other current studies I may qualify for, or for future research.
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If I answered yes, I understand that I may later change my mind, and that I can contact the Sleep and Chronobiology Laboratory Staff in writing to have my contact information destroyed.
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