LAUSR

A randomized, double-blind, cross-over, placebo-controlled clinical study with pyridostigmine bromide (PYD) in obstructive sleep apnea (OSA) patients ranging from mild to moderate disease was conducted to evaluate its clinical efficacy and safety. Six diagnosed male patients with averages of age 48 yr (38 - 57 yr), BMI 28 (26 - 33), AHI 19.2 (15 - 26.2), minimum oxygen saturation (Min SaO2) 81% (75 - 87%) were enrolled to the study. The study consisted one-night acclimatization period followed immediately by a 2-night double-blind treatment period when subjects received either a single dose of PYD (a cholinesterase inhibitor, 90 mg) or placebo before sleep. Subjects were required to maintain in a supine position, and monitored by a standard polysomnography all the time. Sleep questionnaires (The SMH Sleep Questionnaire and ESS) were taken daily immediately after sleep and at the evening to evaluate the sleep satisfaction and the day-time quality, respectively. Safety of the drug was monitored and evaluated. Reductions of AHI (28.1%, p < 0.01), apnea index (37.2%, p < 0.05), % of total apnea/hypopnea time (36.4%, p < 0.05) were observed in the treatment group compared with the placebo between 2-7 hours of sleep. Min SaO2 was increased, no change, or decreased by PYD in 3, 2, or 1 subject(s), respectively. PYD was generally well tolerated with minimum minor incidents. Subjects reported to have more satisfied sleep and more clear-headed in the treatment night, and more energy, more concentrated and less sleepy during the daytime following the treatment night. This study demonstrated the initial effectiveness of the PYD treatment for OSA, indicating that it may provide a new treatment option if the efficacy can be maintained in a large-scale clinical trial. N/A