Teen Night Owl Study
We are studying teen sleep patterns. The results of this study could be used to develop ways to improve the sleep and health of teenagers. Below is a description of the study. When we refer to "you" we are speaking about the teenager who is applying for this study. You will be paid $300 after successful completion of this 3-week study.
Throughout the duration of the study:
- You will wear a wrist monitor, which looks like a wrist watch. It will record movements, and tell us when you are awake and asleep.
- You will be required to keep daily records of events during the day, such as when you are asleep and when you are awake and whether you had caffeine. You may do this using an online form or on paper. If you are female, you will record whether your menstrual period started or not. Before going to bed and when you wake up, you will call a time-stamped voicemail and leave us a short message.
- You will wear a necklace with a small (1-inch by 1-inch) light sensor attached throughout the duration of the study. You will need to make sure that the light sensor is always facing out and on the outside of your clothes and coat.
- You will be required to visit the lab 1 day per week (usually Thursdays after school) to read your wrist activity data and light sensor data into our computer and review your daily records. This is another time to ask questions about the study if you have any. These visits will take 1 to 2 hours.
- You will be able to have a moderate amount of caffeine (no more than 100 mg, which is equal to a cup of coffee or 2 caffeinated sodas) on most days of the study before 2:00 PM; however there are certain days that caffeine intake is not allowed. The days caffeine intake is not allowed are described below.
- You will be asked to provide a urine sample at the beginning of the study, and possibly at random throughout the study, to test for drugs and nicotine. You will also be breathalyzed to test for alcohol at the start of the study and randomly throughout the study.
Baseline Days (Study Days 1-8):
- During these days of the study, you will sleep when you want to sleep.
- After these baseline days, you will be randomly assigned to a study group by chance (like a coin toss). You and the Principal Investigator can’t choose your study group. You will have an equal chance of being assigned to a group. The groups differ by the type of glasses that you wear in the evening and whether or not you have to wake up at a specific time in the morning for the rest of the study (days 10-22). You will be told what group you are in on day 9.
Glasses Days (Study Days 10-22):
- You will be required to wear glasses in the evening every day for about 2 weeks. The glasses we give you block out different types of light from your eyes. We will provide the glasses to you and tell you the exact times that you need to wear them. The time that you begin wearing the glasses each evening will depend on your usual sleep schedule, but it will probably be about 4 to 5 hours before your usual bedtime. You can take the glasses off when you go to bed or after 7 hours, whichever comes first. You will be able to see a television, computer, or other screen while you are wearing the glasses. We will fit the glasses to your head and help you adjust the glasses to be as comfortable as possible.
- A small sensor (smaller than a dime) inside the glasses will allow us to know whether you are wearing the glasses or not.
- You should not wear the glasses if you are driving.
- You may be required to wake up at the same time (+/- 30 mins), including on weekends during these 2 weeks of the study. Wake-up time will be based on your usual wake-up time on school days. The study team will tell you whether you need to wake up at the same time each day or not. If you are asked to wake up at the same time every morning during these 2 weeks, then you will be allowed to take a short (~30 minutes) nap in the afternoon during a “nap zone” that we will set for you.
- We will send you text messages to your cell phone to remind you to put your glasses on each evening at the correct time. If you don’t have a cell phone, we can lend you a cell phone with pre-loaded cards for texting. We are asking for your permission to contact you using a free text messaging service. We will show you how to stop these text reminder if you no longer want to receive them
Lab Nights (Study Days 9 and 23):
- You will not be allowed to use caffeine (e.g., coffee, most sodas, energy drinks, tea, etc.) or products with caffeine (e.g., chocolate) starting about 2 days before the lab nights.
- The two lab nights will start on a Saturday afternoon and end on Sunday. You will stay in our laboratory for the entire lab night (up to 24 hours) and we will measure what time it is in your body clock. During the body clock assessment, you will be asked to stay awake in very dim light in a recliner chair. You will provide a saliva sample (less than a teaspoon of saliva) every 30 minutes by rolling a small (less than 1/2 inch by a little more than 1.5 inches) cylinder of dental cotton around in your mouth. You will provide no more than 25 saliva samples each night. Your saliva will be tested at a later time to determine how much melatonin is in your body. This will tell us what time it is in your brain. During the body clock assessments, you can watch T.V. and movies that have been approved by your parent or legal guardian. You can also play board games or do other quiet activities with other subjects or a member of our research staff. You will not be allowed to use your cell phone, tablet, or anything else with a screen that you hold close to your face.
- After the body clock assessment is over, you will sleep in the lab in your own private room. On Sunday morning, we will wake you up at a time that you, the study coordinator, and your parent or legal guardian agree on. You will leave the lab Sunday soon after you wake up.
- You will complete questionnaires during the lab nights that ask about how you are feeling and your opinion about the glasses.
We have an extensive application process. If, after reading the information, you decide that you want to participate in the study and your parent(s) said it was OK, then please complete all of the questions in the following questionnaire. The first part is for your parent(s) to complete and the second part is for you to complete. Then, we will let you know if you are eligible for the next step in the process of applying for the study. If you are not eligible for the study, we will not be able to tell you why. If, after reading the information about the study, you or your parent(s) are no longer interested in applying, please email us and let us know so we can remove you from our contact lists. Please feel free to contact us if you have any questions or concerns.
Once we receive your completed questionnaire, we will review it and may call you and your parent(s) to collect some additional information. After this follow-up phone call, we may then ask you and one of your parents to come in for an in-person meeting, during which we will explain the study in more detail and show you and your parent(s) the lab and equipment. To determine whether you are eligible for the study, we will also measure your height and weight, give you a vision test, have you and your parent(s) fill in some questionnaires, and have you provide a urine sample for a drug screen test. If you or you parent drives to the lab for this appointment, we will be able to provide you with free parking in the garage attached to our building. Only after that appointment will we be able to tell you if you are eligible to participate in the study. If you are not eligible for the study, we will not be able to tell you why.
If you are still interested, please complete the following questionnaire. If you have questions, please call us at 312-563-4781 or reach us via email at email@example.com. If you complete the questionnaire, you should hear from us within the next few days. Thank you for your interest in the Teen Night Owl Study!
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