← Back to Search

Other

AD109 for Obstructive Sleep Apnea

Phase 3
Recruiting
Research Sponsored by Apnimed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial tests a new sleep apnea treatment compared to a placebo.

Who is the study for?
This trial is for adults over 18 with Obstructive Sleep Apnea (OSA) who have an AHI of >5, mostly non-central apneas, and low sleep movement-related arousal. Participants should be tired often, not currently using or intolerant to PAP therapy, and have a BMI within set limits.Check my eligibility
What is being tested?
The study tests AD109 against a placebo in people with OSA. It's a Phase 3 trial where participants are randomly assigned to either the medication or placebo group without knowing which one they're getting. The comparison lasts for six months.See study design
What are the potential side effects?
Potential side effects of AD109 aren't detailed here but typically include reactions related to the drug's components or its impact on sleep patterns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of AD109 on airway obstruction in mild to sever OSA

Side effects data

From 2021 Phase 2 trial • 60 Patients • NCT04580394
4%
Gastroesophageal reflux disease
2%
Cardiac Arrythmia
2%
Headache
2%
Seizure
2%
Atrial Fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
A: AD109
B: Atomoxetine 75 mg + Placebo
C: R-oxybutynin 2.5 mg + Placebo
D:Placebo + Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AD109Experimental Treatment1 Intervention
AD109
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AD109
2021
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

ApnimedLead Sponsor
13 Previous Clinical Trials
1,395 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently being taken on for this research project?

"Affirmative. Evidenced by clinicaltrials.gov, this medical trial is actively searching for participants since its posting on September 16th 2023 and the latest edit which happened on November 17th 2023. 640 individuals are required at two separate sites to complete the study."

Answered by AI

Has the drug AD109 attained FDA authorization?

"Our experts at Power have attributed a score of 3 to AD109, signifying that there is already empirical evidence backing its effectiveness and safety. This evaluation was made due to the fact this clinical trial has reached Phase 3."

Answered by AI

Are there any available slots to take part in this experiment?

"Indeed, the clinicaltrials.gov website alludes to this research trial actively seeking enrolment. The study was initially publicized on September 16th 2023 and has been amended as recently as November 17th 2023. 640 participants are being sought from 2 different medical sites."

Answered by AI

Who else is applying?

What site did they apply to?
Centennial Medical Group
Core Healthcare Group
Fiel Family Sports Medicine - PC CCT Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Cpap and bipap didnt work. I know I can not tolerate c-pap. I cannot handle a CPAP. And I really want a solution for my apnea.
PatientReceived 1 prior treatment
Always interested in a trial that will help me and educate me on my condition.
PatientReceived 1 prior treatment
I have been on the c-Pap for years but now I have continued to have sinus infections. I have the So Clean nothing works.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
2023. "Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05813275.
All > Fargo
~360 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top