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Sleep Medicine and Research Center: Current Studies

Clinical Trial of an Investigational Drug for the Treatment of Sleep Apnea

WHAT IS THE PURPOSE OF THE STUDY?
The purpose of the study is to examine the efficacy and safety of investigational medications Atomoxetine and Aroxybutynin or Atomoxetine and Trazodone compared to Atomoxetine alone or placebo (an inactive substance) in participants with obstructive sleep apnea (OSA).

WHO CAN PARTICIPATE?
Individuals may be eligible to participate if they:
  • Are male age 18-65 or female age 18-75
  • Have been diagnosed with obstructive sleep apnea or have symptoms of OSA
  • Are not currently using CPAP or other treatments for OSA
  • Have a body mass index (BMI) between 18.5 and 38 kg/m2
  • Sleep more than 5 hours per night
  • Are able to swallow large capsules/tablets
  • Are willing to limit alcohol, caffeine, and tobacco use
WHAT HAPPENS DURING THE STUDY?
A screening office visit and 2 overnight sleep tests are conducted over 2-4 weeks to determine eligibility. Eligible participants will then take the study drug for 4 weeks. During this period, there will be 1 office visit and 2 overnight sleep tests. Participants will be randomly assigned to one of the study drug groups. Participants have a 79% chance of taking an active investigational medication, and a 21% chance of taking placebo. An end of study office visit is conducted 2 weeks after the last dose of study drugs. Participation lasts up to 10 weeks.

Some of the key study procedures conducted include:
  • Review of medical history and current medications
  • Brief physical exam
  • Blood and urine tests
  • Vital signs (blood pressure, pulse, body temperature, respiratory rate)
  • Height and weight
  • ECG (electrocardiogram)
  • Questionnaires about sleep apnea, sleepiness and quality of life
  • Tests of attention, reaction time and memory
  • Overnight sleep tests (to monitor sleep and breathing patterns)

STUDY SCHEDULE
Visit Type of Visit Approximate
Duration in Hours
Details
1 Screening office visit 2 hours ECG, blood and urine collected, vitals, questionnaires
2 Screening overnight visit Overnight
(12 hours)
Sleep testing
3 Screening overnight visit Overnight
(12 hours)
Sleep testing, questionnaires and cognitive tests, study drug dispensed
(Eligible participants will take study drug at home before bedtime nightly for about 1 week)
4 Office visit 1 hour Vitals and weight, study drug collected and dispensed
(Participants will take study drug at home before bedtime nightly for about 2 weeks)
5 Overnight visit Overnight
(12 hours)
Sleep testing, vitals, weight and cognitive testing
(Participants will take study drug at home before bedtime nightly for about 1 week)
6 Overnight visit Overnight
(12 hours)
Sleep testing, ECG, blood collection, vitals, weight, questionnaires and cognitive testing
7 Office visit 1 hour Vitals, weight and questionnaires


WILL IT COST ME ANYTHING TO PARTICIPATE IN THE STUDY?
  • There are no costs to take part in the study. Participants are compensated $75 for each office visit (V1 and V4), $275 for each overnight visit (V2, V3, V5, V6) and $175 for V7. You will be paid up to a total of $1,425.00 if you complete this study.
HOW DO I GET MORE INFORMATION?
Contact us at 314-205-6011 or SLHSleepResearch@stlukes-stl.com.