Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
Study Details
Study Description
Brief Summary
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: AD109 AD109 |
Drug: AD109
Oral administration at bedtime
|
Placebo Comparator: Placebo Placebo |
Drug: Placebo
Oral administration at bedtime
|
Outcome Measures
Primary Outcome Measures
- Efficacy of AD109 on airway obstruction in mild to sever OSA [6 months]
Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥18 years of age at the time of informed consent.
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PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
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PROMIS-Fatigue: raw score ≥17
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PAP intolerance or current PAP refusal.
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BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.
Exclusion Criteria:
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Narcolepsy, restless leg syndrome, REM sleep behavior disorder
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Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms.
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Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
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Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
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Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.
Exclusion Criteria:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Apnimed
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APC-APN-305