Do you experience excessive sleepiness while working the night shift?
See if the SUSTAIN shift work disorder study is right for you.
Do you experience excessive sleepiness while working the night shift?
See if the SUSTAIN shift work disorder study is right for you.
Who Can Participate?
The SUSTAIN shift work disorder study is looking for people who are*:
- Aged 18-65 years old
- Currently experiencing symptoms of Shift Work Disorder (SWD) such as excessive sleepiness and/or insomnia
- Night shift workers with the following schedule:
- Works at least 5 night shifts per month, with at least 3 shifts being consecutive each month
- Night shifts must last at least 6 hours between 10:00 PM and 8:00 AM, but no longer than 12 hours
*Additional eligibility criteria apply
How Do I Participate?
1.
Complete the online questionnaire here to see if you may qualify!
2.
If you meet certain conditions and want to learn more, your information will be sent to a research center near you.
3.
Research center staff will contact you to talk more about the study and get more information on your heath history. You may be invited to the research center to take some tests.
4.
At the research center, the study doctor will talk to you about your participation in the study. After you have asked all of your questions, you will be asked to sign a consent form.
2.
If you meet certain conditions and want to learn more, your information will be sent to a research center near you.
3.
Research center staff will contact you to talk more about the study and get more information on your heath history. You may be invited to the research center to take some tests.
4.
At the research center, the study doctor will talk to you about your participation in the study. After you have asked all of your questions, you will be asked to sign a consent form.
Click the button below to fill out a quick form to see if you may be eligible for the SUSTAIN study.
By filling out this form, you are under no obligation to participate in the study. Your information will be forwarded to the study site closest to you where a member of the staff will reach out via phone, email, or text to collect more information.
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)
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.
*A placebo is a pill that looks like the study drug but does not contain any active ingredients
At the in-clinic visits, you can expect some of the following assessments:
Vital Signs
ECG
Medical History
Blood and Urine Samples
Health Questionna-ire
Sleep and Wakeful-ness Tests*
*Tests at visits 2, 5, 9, and 13. Please note these visits will be approximately 25 hours long and must be scheduled after three consecutive night shifts.
Why Participate?
If you’re living with shift work disorder, the SUSTAIN study may be right for you. If you are eligible to participate:
- You may receive the investigational medication
- You may receive study-related care and study evaluations at no cost
- You may also receive compensation for your time and travel
- You may have the opportunity to help advance new treatments for people with shift work disorder*.
*Solriamfetol is an investigational oral medication being studied for shift work disorder
Click the button below to fill out a quick form to see if you may be eligible for the SUSTAIN study.
By filling out this form, you are under no obligation to participate in the study. Your information will be forwarded to the study site closest to you where a member of the staff will reach out via phone, email, or text to collect more information.
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)
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.
*A placebo is a pill that looks like the study drug but does not contain any active ingredients
At the in-clinic visits, you can expect some of the following assessments:
Vital Signs
ECG
Medical History
Blood and Urine Samples
Health Questionnaire
Sleep and Wakefulness Tests at Visits 2, 5, 9, and 13
Please note these visits will be approximately 25 hours long and must be scheduled after three consecutive night shifts.
*Tests at visits 2, 5, 9, and 13. Please note these visits will be approximately 25 hours long and must be scheduled after three consecutive night shifts.
Why Participate?
If you’re living with shift work disorder, the SUSTAIN study may be right for you. If you are eligible to participate:
- You may receive the investigational medication
- You may receive study-related care and study evaluations at no cost
- You may also receive compensation for your time and travel
- You may have the opportunity to help advance new treatments for people with shift work disorder*.
*Solriamfetol is an investigational oral medication being studied for shift work disorder
What is Shift Work Disorder (SWD)?
Shift work disorder is a sleep disorder characterized by excessive sleepiness, insomnia, and impaired daytime function due to working overnight shifts. 24-hour operations are necessary for public safety, health, and infrastructure, with professions such as nurses, first responders, warehouse workers, and flight crews following these schedules.
These workers are going against the body’s natural internal clock by staying awake at night and trying to sleep during the day, resulting in excessive sleepiness while on the job and insomnia during rest periods.
According to the National Health Interview Survey in 2010, nearly one third of Americans work an alternate shift outside a 7 AM to 6 PM workday, and of these more than 9.5 million people work overnight or rotating shifts1.
If you believe you may be living with SWD, fill out the form above to speak with a sleep disorder expert.
References
[1] T. Alterman, S. E. Luckhaupt, J. M. Dahlhamer, B. W. Ward, and G. M. Calvert,
“Prevalence rates of work organization characteristics among workers in the U.S.: data from the 2010 National Health Interview Survey,” Am. J. Ind. Med., vol. 56, no. 6, pp. 647–659, Jun. 2013, doi: 10.1002/ajim.22108.
Shift work disorder is a sleep disorder characterized by excessive sleepiness, insomnia, and impaired daytime function due to working overnight shifts. 24-hour operations are necessary for public safety, health, and infrastructure, with professions such as nurses, first responders, warehouse workers, and flight crews following these schedules.
These workers are going against the body’s natural internal clock by staying awake at night and trying to sleep during the day, resulting in excessive sleepiness while on the job and insomnia during rest periods.
According to the National Health Interview Survey in 2010, nearly one third of Americans work an alternate shift outside a 7 AM to 6 PM workday, and of these more than 9.5 million people work overnight or rotating shifts1.
If you believe you may be living with SWD, fill out the form above to speak with a sleep disorder expert.
References
[1] T. Alterman, S. E. Luckhaupt, J. M. Dahlhamer, B. W. Ward, and G. M. Calvert,
“Prevalence rates of work organization characteristics among workers in the U.S.: data from the 2010 National Health Interview Survey,” Am. J. Ind. Med., vol. 56, no. 6, pp. 647–659, Jun. 2013, doi: 10.1002/ajim.22108.
Shift Work Disorder Resources
FAQs
What is a clinical research study?
A clinical research study, also called a clinical trial, tests the safety and efficacy of an investigational medicine in human volunteers. Every medication on the market has gone through this process, meaning volunteers are an important part of advancing medicine for present and future generations.
What is the investigational medication being researched in this study?
Solriamfetol is the investigational oral medication being researched in this study. It has been approved by the U.S. Food and Drug Administration (FDA) for people who have excessive daytime sleepiness associated with narcolepsy or 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. In this study, researchers want to know if solriamfetol can improve wakefulness during night shifts for people with SWD and if it is safe for use in this indication.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by a pharmaceutical or biotechnology company, academic medical center, or health care provider. Every clinical study is held at one or more sites that are led by a principal investigator (study doctor) and their research team.
What is a placebo?
A placebo looks like the investigational medication but does not contain any active ingredients (medicine). Taking placebo is as if the participant was not taking anything at all. In this study, placebo is used to compare the effects of the investigational medication. Neither the participant nor the study doctor will know if they are taking the investigational medication or placebo. In case of a medical emergency, the study doctor will be able to find out which group the participant belongs to.
What does it mean to participate? Is it voluntary?
In order to participate in a study, you will need to first take some tests and discuss your medical history with the study doctor to ensure that you meet all criteria for participation. You will also review and sign an informed consent form which lays out what will happen in the study, your rights and responsibilities as a participant, and the risks and potential benefits of the study. Once you are eligible and enrolled, you will visit the study site regularly to monitor your progress and overall health.
Yes, study participation is absolutely voluntary. You have the right to end participation at any time for any reason. In case you decide to drop out of the study, please speak with the study doctor first.
How can I learn more about the study and its sponsor?
For more information about the study, visit https://clinicaltrials.gov/study/NCT06568367.
For more information about Axsome Therapeutics, the study sponsor, visit axsome.com.