AD109 Dose Finding in Mild to Moderate OSA (NCT04631107) | Clinical Trial Compass
CompletedPhase 2
AD109 Dose Finding in Mild to Moderate OSA
United States32 participantsStarted 2020-12-22
Plain-language summary
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* AHI between 5 and 20 events/h
* PGI-S equal to or higher than 1, or one or more of the following symptoms:
* Snoring or nightime gasping/choking
* Daytime sleepiness, fatigue or decreased concentration
* Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
* Irritability, decreased mood or libido
Exclusion Criteria:
* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
* CPAP should not be used for at least 2 weeks prior to the study
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
Timeframe: 1 night (8 hours)
2
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]