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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 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
Awards & highlights
Summary
This trial involves giving multiple doses of a treatment to people with Obstructive Sleep Apnea (OSA) to see if it helps improve their condition. Recently, combined agents have been evaluated for the treatment of OSA in several trials.
Eligible Conditions
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo
Trial Design
6Treatment groups
Experimental Treatment
Group I: Order: Period C, Period B, Period AExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group II: Order: Period C, Period A, Period BExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group III: Order: Period B, Period C, Period AExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group IV: Order: Period B, Period A, Period CExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group V: Order: Period A, Period C, Period BExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group VI: Order: Period A, Period B, Period CExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Period C
2023
Completed Phase 2
~30
Period A
2023
Completed Phase 2
~30
Period B
2023
Completed Phase 2
~30
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Who is running the clinical trial?
ApnimedLead Sponsor
14 Previous Clinical Trials
2,150 Total Patients Enrolled
Ronald Farkas, MDStudy DirectorApnimed Inc.
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