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Sleep Medicine and Research Center: Current Studies

Research Study for Patients with Obstructive Sleep Apnea (OSA) and Excessive Daytime Sleepiness

WHAT IS THE PURPOSE OF THE STUDY?

The purpose of this study to find out whether a drug improves mental function in people with obstructive sleep apnea who feel very sleepy in the daytime. The drug (solriamfetol) has been approved by the United States Food and Drug Administration (FDA) to treat excessive sleepiness in people with obstructive sleep apnea. The use of solriamfetol for improving mental function is investigational.

The research study is approved by the St. Luke’s Institutional Review Board and the United States FDA.

WHAT HAPPENS DURING THE STUDY?

Participation in the study lasts 7-11 weeks and involves approximately 5 visits to the Sleep Medicine & Research Center and reminder phone calls.

Visits/Procedures
  • Screening Office Visit(s): (4-6 hours at one or more visits in the morning)
    • Height and weight
    • Questions about how the participants are feeling, sleeping habits, smoking/nicotine habits, and caffeine intake
    • Demographics, health, and medications
    • Physical examination
    • Alcohol breath test
    • Vital signs (blood pressure, body temperature, breathing rate, and heart rate)
    • Blood and urine collection (test for infections, medical issues, drug use, and pregnancy)
    • Electrocardiogram (ECG) to monitor heartbeat
    • Tests of mental function
    • Questionnaires
    • Provide study instructions, restrictions, and sleep diary
    • Information will be obtained from positive airway pressure devices (if using one)

  • Baseline Visit: 2-4 weeks after screening visit (9-10 hours at Sleep Center beginning around 8:30 am)
    • Review health, medications, sleep diary and positive airway pressure device data (if using one)
    • Weight and vital signs
    • Questions about how participants are feeling, caffeine intake and smoking/nicotine habits
    • Alcohol breath test
    • Urine drug screen and pregnancy test (if applicable)
    • Tests of mental function
    • Questionnaires
    • Eligible participants will be provided drug (solriamfetol or placebo), instructions, and a sleep diary

  • Part 1: Take study medication every morning for 2 weeks at home and complete the diary as instructed

  • End of Part 1: 2 weeks after Baseline visit  (9-10 hours at Sleep Center beginning around 8:30 am)
    • Review health, medications, sleep diary, and positive airway pressure device data (if using one)
    • Weight and vital signs
    • Questions about how participants are feeling, caffeine intake and smoking/nicotine habits
    • Alcohol breath test
    • Urine drug screen and pregnancy test (if applicable)
    • Tests of mental function
    • Questionnaires
    • Provided drug (solriamfetol or placebo), instructions, and a sleep diary

  • Washout period: No study medication for 1 week

  • Part 2: Take study medication every morning for 2 weeks at home and complete the diary as instructed

  • End of Part 2
    • 2 weeks after starting study medication
    • 9-10 hours at Sleep Center beginning around 8:30 am
    • Same procedures as End of Part 1 (except not provided drug or sleep diary)

  • End of Study Office Visit: 4-10 days after End of Part 2 (10 minutes)
    • Phone call or a study center visit to check on overall health and medications
    • Urine pregnancy test (if applicable)

  • Reminder phone calls: Before each visit and before Part 2

SCHEDULE OVERVIEW

VISIT NAME

VISIT TYPE

DURATION

DAYS TO NEXT VISIT AT THE CENTER

SCREENING

SLEEP CENTER

5 HOURS

14-28

BASELINE

SLEEP CENTER

10 HOURS

14

PART 1: Take active drug or placebo each morning for 2 weeks

END OF PART 1

SLEEP CENTER

10 HOURS

21

1 week at home without study drug

PART 2: Take active drug or placebo each morning for 2 weeks

END OF PART 2

SLEEP CENTER

10 HOURS

4-10

END OF STUDY

PHONE CALL OR SLEEP CENTER

10 MINUTES

 



WHO IS ELIGIBLE FOR THE STUDY?

Patients may be eligible if they: 

  • are between 18 – 65 years of age
  • have a body mass index (BMI) below 40 kg/m2
  • are currently diagnosed with obstructive sleep apnea (OSA)
  • are using positive airway pressure (PAP), have tried PAP, or have had a surgery to treat OSA
  • have a hard time staying awake during the day
  • have difficulty concentrating due to daytime sleepiness
  • have not taken solriamfetol before

Some medications cannot be taken during the study. Other eligibility requirements will be reviewed by the study staff.

DOES IT COST ANYTHING TO PARTICIPATE IN THE STUDY?

There are no costs to take part in the study. Study drug is provided at no cost. Participants are paid up to $600 ($100 for screening visit, $150 for each full day testing visit [Baseline, End of Part 1 and End of Part 2], $50 for the End-of-Study visit). Participants are paid only for the visits that are completed.

HOW DO I GET MORE INFORMATION?

Contact us at (314) 205-6011 or SleepResearch@stlukes-stl.com