Shift Work Disorder
The SUSTAIN Shift Work Disorder Study is looking for people who are:*
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Aged 18–65 years old
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Currently experiencing symptoms of Shift Work Disorder (SWD), such as excessive sleepiness and/or insomnia
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Night shift workers with the following schedule:
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Work at least 5 night shifts per month, with at least 2 consecutive shifts each month
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Night shifts must last at least 6 hours between 10:00 PM and 8:00 AM, but no longer than 12 hours
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Additional eligibility criteria apply.
About the Study
If you meet the above criteria, the SUSTAIN shift work disorder research study may be of interest to you. This study is evaluating an oral investigational medication (solriamfetol) in adults with SWD. Solriamfetol is approved by the FDA for people who have excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea (OSA), which are other sleep-related disorders. Solriamfetol is an investigational treatment for SWD, meaning it has not yet been approved by any health authority for the treatment of SWD. Eligible participants will receive study-related care and evaluations at no cost. Each participant’s SWD and overall health will be monitored by a team of physicians and study staff. Compensation for your time and travel may be available.
What to Expect
If you are eligible and choose to participate in the SUSTAIN study, you may be in the study for up to 18 weeks. There are 6 in-person visits at the study site you choose and up to 8 remote visits by phone. As a participant in the study, it is important to understand how many visits you need to attend when you make the decision to participate.
Screening Period (Up to 4 weeks)
Screening Period (Up to 4 weeks) This is the time when the study doctor and staff determine if you are eligible for the study. You will come in for your first visit and will answer some questions and do some medical tests to see if you may be a good fit for the study. You will be asked to complete a daily electronic diary to track your work and sleep symptoms
Study Treatment Period
(12 weeks)
If you are eligible to participate, you will then enter the study treatment period which lasts for 12 weeks and involves up to 5 in-person visits and up to 7 remote visits. You will be randomly assigned to take either solriamfetol or placebo* 30-60 minutes before every night shift. You will also continue your electronic diary and complete a paper dosing diary every time you take the study medicine.
Follow-Up Period (1 week)
At the end of the study, you will be contacted via phone by the site 1 week after your final in-person visit to check in and see how you are doing.
At the in-clinic visits, you can expect some of the following assessments:
The assessments performed may vary depending on your individual visit schedule.
Vital Signs
Vital signs are simple measurements that show how well your body is working. They include:
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❤️ Heart Rate – How fast your heart is beating.
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🩺 Blood Pressure – How hard your blood is pushing through your blood vessels.
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🫁 Breathing Rate – How many breaths you take in a minute.
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🌡️ Temperature – Checks if your body is too hot or too cold.
ECG
EKG (Electrocardiogram) ❤️
An EKG is a simple, painless test that checks your heart's electrical activity. It shows how fast your heart is beating and whether it is beating in a normal rhythm. Small stickers are placed on your chest, arms, and legs to record your heart's signals.
Blood and Urine Sample
Blood and urine samples are collected to help researchers learn more about your health and how your body responds during the study. These tests help make sure it is safe for you to participate and provide important information for the research.
Review of Medical History
A review of your medical history is a discussion about your past and current health, including any medical conditions, medications, surgeries, and treatments. This helps the study team understand your health background and determine if the study is a good fit for you.
Health Questionnaires
Health questionnaires are simple surveys that ask about your health, symptoms, sleep, daily activities, and overall well-being. Your answers help the study team better understand your experiences and how the condition affects your daily life.
Sleep and Wakefulness Tests at Visits 2, 5,and 13
Please note these visits will be approximately 25 hours long and must be scheduled after Two consecutive night shifts
