WHAT IS THE PURPOSE OF THE STUDY?
The purpose of the study is to examine the efficacy and safety of the investigational medication AD109 (a combination of Atomoxetine and Aroxybutynin) compared to placebo (an inactive substance) over a 1-year period in patients with obstructive sleep apnea (OSA).

WHO CAN PARTICIPATE?
Individuals may be eligible to participate if they:

• Are age 18 or older
• Have been diagnosed with OSA
• Are unable or refuse to use available treatments for OSA
• Have a body mass index (BMI) between 18.5 and 40 kg/m2 (men) or 42 kg/m2 (women)
• Are willing to limit alcohol, THC/marijuana, caffeine, and tobacco use

WHAT HAPPENS DURING THE STUDY?
The Screening Period includes 2 office visits and 1 overnight sleep visit conducted over 2-4 weeks to determine eligibility. Eligible participants will take the study drug for 51 weeks. During this period, there will be 2 office visits, 3 overnight visits and 10 phone calls. Participants will have a 50% chance of taking AD109, and a 50% chance of taking placebo. An end of study office visit is conducted 2 weeks after the last dose of study drug. Participation lasts about 13 months.

Some of the study procedures conducted during visits include the following:

• Review of medical history, current health, and prior and current medications
• Brief physical examination
• Blood and urine tests
• Vital signs (blood pressure, pulse, body temperature, and respiratory rate)
• Height and weight
• ECG (electrocardiogram)
• Questionnaires about sleep apnea, sleepiness and how you are feeling
• Tests of attention, reaction time and memory
• Overnight sleep testing (to monitor sleep and breathing patterns)

STUDY SCHEDULE

VISIT	VISIT TYPE	DURATION	DETAILS
1	OFFICE VISIT	DAYTIME 2 HOURS	REVIEW MEDICAL HISTORY, PRIOR AND CURRENT MEDICATIONS. PHYSICAL EXAM, ECG, BLOOD AND URINE COLLECTED, VITALS AND QUESTIONNAIRES
2	SLEEP LAB VISIT	OVERNIGHT (12 HOURS)	OVERNIGHT SLEEP TESTING, VITALS, QUESTIONNAIRES AND TESTS OF ATTENTION, REACTION TIME AND MEMORY
3 (DAY 1)	OFFICE VISIT	DAYTIME 30 MINS	STUDY DRUG COLLECTED AND DISPENSED, VITAL SIGNS AND 24-HOUR BLOOD PRESSURE MONITORING (OPTIONAL)
4 (WEEK 4)	OFFICE VISIT	DAYTIME 1 HOUR	STUDY DRUG COLLECTED AND DISPENSED, VITALS, WEIGHT, QUESTIONNAIRES AND 24-HOUR BLOOD PRESSURE MONITORING (OPTIONAL)
5 (WEEK 13)	SLEEP LAB VISIT	OVERNIGHT (12 HOURS)	STUDY DRUG COLLECTED AND DISPENSED, SLEEP TESTING, VITALS, WEIGHT, QUESTIONNAIRES AND COGNITIVE TESTING
6 (WEEK 26)	SLEEP LAB VISIT	OVERNIGHT (12 HOURS)	STUDY DRUG COLLECTED AND DISPENSED, SLEEP TESTING, VITALS, WEIGHT, BLOOD AND URINE COLLECTION, QUESTIONNAIRES AND COGNITIVE TESTING
7 (WEEK 39)	OFFICE VISIT	DAYTIME 1 HOUR	STUDY DRUG COLLECTED AND DISPENSED, VITALS, WEIGHT, AND QUESTIONNAIRES
8 (WEEK 51)	SLEEP LAB VISIT	OVERNIGHT (12 HOURS)	SLEEP TESTING, VITALS, WEIGHT, BLOOD AND URINE COLLECTION, QUESTIONNAIRES AND COGNITIVE TESTING, AND STUDY DRUG COLLECTED
9 (WEEK 53)	OFFICE VISIT	DAYTIME 1 HOUR	VITALS, WEIGHT, ECG, 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 as follows:

VISIT	PAYMENT
Screening Office Visit 1	$100
Screening PSG Visit 2	$275
Office Visit 3 (with optional 24-hour blood pressure monitoring)	$200
Office Visit 3 (without optional 24-hour blood pressure monitoring)	$100
Office Visit 4 (with optional 24-hour blood pressure monitoring)	$150
Office Visit 4 (without optional 24-hour blood pressure monitoring)	$100
PSG Visit 5	$275
PSG Visit 6	$275
Office Visit 7	$100
PSG Visit 8	$275
Office Visit 9	$100
Telephone Calls (10 total)	$25 each

HOW DO I GET MORE INFORMATION?
Complete the questions below and we will contact you for further information or call 314-205-6011.