Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

Inclusion criteria

• ≥18 years of age at the time of informed consent.
• PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
• PROMIS-Fatigue: raw score ≥17
• PAP intolerance or current PAP refusal.
• BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

Exclusion criteria

• Narcolepsy, restless leg syndrome, REM sleep behavior disorder
• 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.
• Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
• Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
• Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.