Teen Sleep and Light Study Survey |
Introduction:
We are studying the effects of light on the timing of the body clock after teenagers (ages 14-17) have had different durations of sleep. 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. Parents can substitute "your child" in place of "you.
This study is 14 days long. If you successfully complete the study you will receive $975. There will be two other teenagers participating in the study at the same time as you. The study is separated into 2 parts, a "home sleep week" (7 days) and a "lab week" (7 days). Below we describe what procedures occur throughout the study. Then, we describe what will occur during the home sleep week and the lab week.
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 when you are asleep. You will also wear a necklace with a small (1-inch by 1-inch) light sensor attached throughout the duration of the study; it looks like a medallion. 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 also be required to keep daily records of your sleep times and other events that occur each day. You may do this using an online form or on paper. Caffeine, nicotine, alcohol, and drugs are not allowed throughout the study. You will be asked to provide a urine sample at the beginning of the study for a drug/nicotine screen. You may also be randomly drug tested throughout the duration of the study. We will not share the results with your parent(s)/legal guardian. You may be required to take a COVID-19 test when you start the study. This would require you to swab the inside of your nose.
Home Sleep Week (Study Days 1-7):
While at home you will be asked to call our lab voicemail when you go to bed and after waking up every day. Because the study requires frequent phone contact, it is important that you have a phone to use while in the study. We will send you text message reminders on your cell phone for various study related tasks while you are sleeping at home. If you don’t have a cell phone, we can lend you a cell phone with pre-loaded cards for texting. We will ask for your permission to contact you using a free text messaging service. We will show you how to stop these text message reminders if you no longer want to receive them.
At home you will follow a rigid (strict) sleep schedule, with bedtimes and wake times similar to your usual sleep schedule. You will always have the same bedtime and same wake up time, even on the weekends. You will be required to sleep at home in the dark for 10 hours each night. You must be lying in your bed in the dark trying to sleep during the sleep times. You may not read, use a computer or electronic device, watch television, listen to music, or use your cell phone during this scheduled sleep time. You will not be allowed to sleep at other times outside of your scheduled sleeping hours.
You will also be required to visit the lab once during the week that you sleep at home. During this lab orientation day, you will deliver us your daily questionnaires and we will read (download) the data from the equipment you wear into our computer. This visit will also require you to learn and practice some of the computerized study tests, learn how to give a saliva sample, meet the other study participants (one or two) that you will be hanging out with in the lab, and meet the study staff. You will remain in the lab for about 7.5 hours this day, food and beverages will be provided. This is another time to ask questions about the study if you have any. You will need to wear a mask while you are in the lab on this day to prevent risk of COVID-19 transmission.
Lab Week (Study Days 8-14):
During the lab week, you will stay in our lab for a total of 7 days. You must remain in the lab the entire time. A research staff member will always be in the lab when you are, even while you are sleeping. They will tell you what you need to do, prepare you food, and so forth. Food and beverages will be provided when you are in our lab, but some foods that could interfere with the study (such as, caffeine, bananas, and chocolate) will not be allowed. You will also be breathalyzed for alcohol at the start of the lab week.
You will complete performance tasks throughout the lab week. You may also complete some questionnaires that ask you how you are feeling every once and a while when you are in the lab.
You will complete a lazy boy session when you arrive for the lab week (study day 8). During a lazy boy session you will be asked to stay awake in dim red light in a lazy boy recliner chair for no more than 13 hours. You will provide a saliva sample (less than 1/2 teaspoon of saliva) every 30 minutes by rolling a small (1 x 4 cm) cylinder of dental cotton around in your mouth. You will provide no more than 25 saliva samples during the first lazy boy session. 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 lazy boy session, you can watch T.V. and movies that have been approved by your parent or legal guardian. You can also play games or do other quiet activities with other participants and a member of our research staff. After the lazy boy session is over, you will sleep in our lab in your own private bedroom. We will tell you when it is time to go to bed and when to wake up.
On lab nights 9 and 10, you will be assigned a sleep duration that is between 5.5 and 10 hours long. You will be randomly assigned to a sleep duration group by chance (like a coin toss). You and the study doctor cannot choose your sleep duration group. You will have an equal chance of being assigned to a group. We will tell you what sleep duration group you are in before you arrive. We will put you to bed at your usual time (like in the home sleep week) or we will put you to bed up to 4.5 hours later than your usual time. You will wake up at your usual time. Therefore, you may or may not get less sleep than you are used to.
On lab nights 11, 12, and 13, you will have the same amount of time to sleep as nights 9 and 10 (between 5.5 and 10 hours). On these nights, however, your sleep schedule will move earlier each night by a few hours. When you wake up on the next day, you will sit in front of light boxes with fluorescent bulbs for 1.5 hours on each morning. The lights will produce bright light that is brighter than most indoor light, but not as bright as being outside on a cloudy day. Light boxes are safer than sunlight because they do not contain ultraviolet (UV) light. There are no known harmful effects from light of this intensity, but rarely people experience headaches.
In the few hours before you go to bed each night in the lab, you may be required to wear sunglasses. The glasses we give you will 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. You will begin wearing the glasses each evening close to your usual bedtime. 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.
On the last lab day (study day 14), you will complete a second lazy boy session. This lazy boy session is exactly like the one described above on study day 8, except that it will be longer. The second lazy boy session will be no more than 16.5 hours. You will provide no more than 32 saliva samples. After the second lazy boy session is over, you will sleep in our lab in your own private bedroom. We will tell you when it is time to go to bed. We will wake you up at your scheduled wake time the next morning and you will go home. You will need to wear a mask while you live in our lab, except when you are providing a saliva sample, eating, or sleeping.
Application Process:
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 questionnaire and return it to us via email. The first part is for your parent(s) to complete and the second part is for you to complete. Once we receive your completed questionnaire, we will review it and let you know if you are eligible for the next step in the process of applying for the study.
We 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 meet with us virtually via WebEx. During this meeting we will explain the study in more detail, show you and your parent(s) pictures of the lab and equipment, and have you and your parent(s) fill in some questionnaires. 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 and submit the following questionnaire. If you have any additional questions please email us at: sleep_study_3@rush.edu or call us at 312-563-4781. If you return the filled out questionnaire, you should hear from us within the next few days.