Clinical Trial 61815

Middletown, NJ 07748


Summary:

<b>Shift Work Sleep Disorder - Multiple Locations in the US</b>

Recruiting Participants for the SUSTAIN Shift Work Disorder Research Study

Are you living with shift work disorder (SWD)? Are you feeling excessive sleepiness while working the overnights? Do you have trouble falling asleep after your night shift?

What is the SUSTAIN shift work disorder research study?

The SUSTAIN study is a clinical research study currently being conducted at select centers in the US. The study is for people aged 18 to 65 who are living with excessive sleepiness associated with the shift work schedule*. The SUSTAIN study is evaluating an oral investigational medication (solriamfetol) in adults with Shift Work Disorder (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.

*Other criteria also apply.

What is shift work disorder?

Shift work disorder is characterized by excessive sleepiness, insomnia, and impaired daytime functioning resulting from a mismatch between the body’s internal clock and the required work schedule, primarily affecting people with non-standard work shifts, such as overnights. According to the National Health Interview Survey in 2010, nearly one third of Americans work an alternate shift outside a 7AM to 6PM workday, and of these more than 9.5 million work overnight or rotating shifts1.

Who Can Participate?

People who are aged 18 to 65 in the U.S. who have experienced symptoms of shift work disorder over the last 3 months may be eligible. Other criteria also apply.

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 potential new treatments for people with shift work disorder*.

*Solriamfetol is an investigational oral medication being studied for shift work disorder.

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.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.