Cannabimimetic Treatment of Obstructive Sleep Apnea: A Proof of Concept Trial

Exclusion criteria

• Arterial oxygen saturation \< 75% for \> 5% of sleep period time on screening PSG;
• Occupation or life situation that may impart risk by study participation (e.g. commercial driver, pilot, police officer, fireman);
• Motor vehicle accident or "near-miss" related to sleepiness (self-report) within 2 years of the first dose of study drug (Day 8);
• Body mass index \> 45 kg/m2
• Severe obstructive sleep apnea syndrome (OSAS) that, based on the clinical judgment of the Investigator, precludes delaying positive airway pressure treatment;
• History of shift work or rotating shifts within the month prior to the first dose of study drug (Day 8);
• Prior upper airway surgery for snoring or OSAS as an adult (≥ 18 years of age);
• Prior non-invasive treatment for OSAS within 6 months prior to the first dose of study drug (Day 8);
• Major surgery within 6 months prior to the first dose of study drug (Day 8);
• Bariatric surgery within 2 years prior to the first dose of study drug (Day 8). If post-bariatric surgery, weight must be stable ±5% (self-report) for at least 6 months prior to first dose of study drug (Day 8).
• Any form of medically managed weight loss program within 6 months prior to the first dose of study drug (Day 8);
• Significant defect in nasal patency due to anatomical abnormalities or uncontrolled or recurrent episodes of rhinitis;
• Any clinically significant unstable or progressive medical condition;
• Any primary sleep disorder other than OSAS as determined by history, physical examination, or Visit 2 PSG (after 7-day screening run-in period);