Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel Inhibitor

Exclusion Criteria

• •Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection and attending required follow up study visits.
• •Neck circumference above/equal 44 cm.
• •Not predominantly obstructive sleep apnea evidenced by baseline PSG.
• •Severely impaired breathing within two days prior to randomization (e.g. acute nasal congestion during upper airway infection).
• •Subject with known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations). Known severe respiratory tract allergies e.g. allergic asthma.
• •Intake of a nasal decongestant during the intervention time (48 hours before visit 1 until end of visit 2).
• •Use of any topical medication containing local anesthetics for nose and throat within 7 days before first investigational medicinal product (IMP) administration.
• •Participation in another trial with an investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer before first application of study drug or concomitant participation in another clinical study with investigational medicinal product(s).
• •Any other condition, which would make the subject unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months)
• •Known history of severe heart failure (NYHA 3-4) or severe COPD (GOLD 3-4).
• •Heavy smoking, i.e. more than 20 cigarettes per day and/or unable to stop smoking during the stay in the sleep laboratory.
• •Suspicion of drug or alcohol abuse.
• •Regular daily consumption of more than 1 L of xanthine-containing beverages.