What is the Purpose of the Study?
The purpose of the study is to assess the safety and efficacy of an investigational medication called solriamfetol in the treatment of Shift Work Disorder. Solriamfetol is approved by the U.S. Food and Drug Administration for people who have excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea.
Who Can Particpate?
Individuals may be eligible to participate if they:
- Are 18 to 65 years of age
- Work at least 5 night shifts per month with at least 3 night shifts in a row
- Work at least 6 hours between 10:00 PM and 8:00 AM, but no longer than 12 hours
- Have never taken solriamfetol (or Sunosi®)
- Have sleepiness during their night shifts and trouble sleeping during the day
- Are willing to abstain from consuming alcohol and THC/cannabis, and limit caffeine consumption
Some medications cannot be taken during the study. Other eligibility requirements will be reviewed by the study staff.
What Happens During the Study?
Participation lasts for about 17 weeks. There is a screening period to determine eligibility. During this period, there will be an office visit and a sleep test visit. Participants meeting all entry criteria will be randomized (like flipping a coin) to take solriamfetol or placebo prior to each night shift for 12 weeks. There is a 66% chance of receiving solriamfetol, and a 33% chance of receiving placebo. During this period, there will be approximately 4 office visits, 7 telephone calls, and 3 sleep test visits (once per month).
Some of the study procedures conducted during visits include the following:
- Review of medical history, current health, and prior and current medications
- Physical examinations
- Blood, urine, drug screen, alcohol, and pregnancy tests
- Vital signs (blood pressure, pulse, body temperature, and respiratory rate)
- Height and weight
- ECG (electrocardiogram)
- Questionnaires about your symptoms and how they affect your daily functioning as well as how you are feeling
- Electronic daily diary to track work, sleep, dosing, and symptoms
- Sleep test visits (4 total) take about 25 hours and include an in-lab daytime sleep test and nighttime wakefulness testing.
Will It Cost Me Anything to Participate in the Study?
There are no costs to take part in the study. Participants are compensated for each completed visit totaling up to $1,800.
How Do I Get More Information
Complete the questions below and we will contact you for further information or call 314-205-6011.