Efficacy of Armodafinil in Moderate to Severe Obstructive Sleep Apnea Patients with Residual Excessive Daytime Sleepinesss after Suboptimal Usage of Continuous Positive Airway Pressure Treatment: A Prospective Cohort Study

Ratchadapiseksompoj funds0 个研究点目标入组 30 人开始时间: 2021年2月18日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patient who diagnosed with moderate to severe OSA and still have excessive daytime sleepiness defined as ESS >10 and have received stable CPAP therapy at least 4 weeks but in suboptimal usage
•patient naive to Armodafinil

•1.Patient who was diagnosed with sleep disorders other than OSA
•2.Patient who has clinically significant or uncontrolled medical condition, treated and untreated, or any disorder that might interfere with drug absorption, distribution, metabolism, excretion or produce daytime sleepiness
•3.Patient use prescription drugs disallowed by protocol* or clinically significant use of over-the-counter drugs within 7 days before baseline visit
•4.Patient with history of alcohol, narcotics, or any other recreational drug abuse
•5.Patient with excessive consumption of caffeine > 600 mg/day or > 8 cups/day
•6.Patient who is pregnancy or lactation
•7.Patients with psychiatric disorders
•8.Patients with cardiovascular disorder
•- History of Left Ventricular Hypertrophy (LVH)
•- Mitral Valve Prolapse (MVP) who have experienced MVP syndrome with previous CNS stimulant exposure
•- Unstable Cardiovascular (CV) disease
•- Moderate to severe symptomatic Cardiovasbular (CV) disease
•9.Patients with abnormal ECG at baseline or uncontrolled blood pressure ( >180/100 mmHg)

发起方

Ratchadapiseksompoj funds