What is SLEAP? 

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As you might have guessed from the title, this sub-study of LEAP is all about sleep! The goal is to better understand how the study treatment in LEAP impacts sleep and daily patterns of rest and activity. We are interested in capturing LEAP participants’ ‘typical’ sleep habits during treatment; everything is done at home. To do this, we ask LEAP participants to complete questionnaires about their sleep habits, fill out daily sleep diaries, and wear sleep monitoring devices for multiple days at different timepoints during the study. The ‘sleep assessment’ periods align with the existing baseline, 6-, 12-, and 24-month LEAP visits. Because all of the study measures are collected under ‘free-living’ conditions, no additional visits to the clinic are needed!   

 

Why are we interested in sleep? 

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It is becoming more and more apparent that sleep plays an important role in weight management. How well a person sleeps can affect the behaviors that determine weight change, such as eating patterns and physical activity levels. We are interested in studying how different types of treatments, including anti-obesity medications, affect a person’s sleep. Along with this, we want to understand how a person’s sleep during treatment influences their weight loss. 

 

How do we measure sleep? 

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We use a variety of tools to measure sleep. Sleep is complex, and each tool provides a different type of information. We know that LEAP participants are busy, so we worked hard to select measures that require as little effort as possible. As mentioned before, because we are interested in your typical, everyday habits, all of the measures are collected outside of the clinic. 

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To evaluate chronic sleep habits, symptoms of disordered sleep, and how you feel about your sleep, we use short electronic questionnaires. These are sent to you once per sleep assessment period and can be completed on any electronic device with internet access. We also measure sleep using wearable devices. The primary device we use is a wrist-worn monitor that we call an ‘Actiwatch’. The Actiwatch is worn just like a watch, but instead of measuring time, it measures movement and light. It’s doing this continuously, so it needs to be worn at all times. From the Actiwatch, we can get specific data on when you sleep and when you are awake at every moment. We pair those data with information from short sleep diaries, which are sent to you daily and completed electronically, for more personalized information. Together, those data are computed to provide measures of your sleep. You will wear the watch for 1 week to give us a good sense of your typical sleep duration and quality.  

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For participants from the Wake Forest clinical sites, we will gather even more detailed data on sleep through self-administered home sleep tests. Wake Forest-based SLEAP participants will complete home sleep tests during the first 2 nights that they wear the Actiwatch. The home sleep test is similar to the sleep tests done in sleep clinics; however, the device we use, a ZMachine, was developed specifically for at-home use. It is self-administered and far less cumbersome than clinic-based sleep test equipment.. The ZMachine collects data across multiple ‘channels’, allowing for precise and thorough information on sleep, including sleep architecture (how much time you spend in light, deep, and REM sleep), breathing during sleep, snoring, and even how much time you spend laying in different positions. 

 

Does SLEAP require extra clinic visits? 

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No! The sleep sub-study is completely ‘home-based’. We mail devices directly to you after you complete the baseline, 6-, 12-, and 24-month visits (for participants who have already completed some of these LEAP study visits, you will pick up with SLEAP at the next one of the timepoints listed).  Within the padded mailer, we also provide packaging to return the devices by mail. All of the shipping is paid in advance by the researchers, so devices just need to be dropped off at your nearest post office or FedEx location. 

 

Who can participate in SLEAP? 

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SLEAP is open to anyone participating in the LEAP trial who has not yet completed their 12-month clinic visit.  

 

Does SLEAP provide compensation for participating?  

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YES! We have done our very best to make the SLEAP sub-study super easy for you. We want it to be enjoyable and not an additional burden. However, we recognize that everyone is busy, and time is valuable. Therefore, we will provide you with compensation for completing each sleep assessment period. More information on compensation is provided in the consent form.  

 

Can participants see their sleep data? 

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Yes! We are happy to provide any participant with their sleep data at the end of the study.