Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Apnimed
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. ≥18 years of age at the time of informed consent.
2. PSG criteria: AHI of \>5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
3. PROMIS-Fatigue: raw score ≥17
4. PAP intolerance or current PAP refusal.
5. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.
You may not be if
1. Narcolepsy, restless leg syndrome, REM sleep behavior disorder
2. 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.
3. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
5. Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.
Clareo Health | Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
