Minimum effective dose-finding study of BF2.649, in patients with moderate to severe Obstructive Sleep Apnea, experiencing Excessive Daytime Sleepiness (EDS) despite regular use of nCPAP, and patients having refused this therapy. Randomized, double blind study with BF2.649 (5-, 10-, 20-, 40- mg/d), or placebo

Bioprojet0 个研究点目标入组 120 人开始时间: 2010年6月4日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•- Patients having been submitted to nCPAP therapy for a minimum period of 3 months, and still complaining of Excessive Daytime Sleepiness despite the efforts made beforehand to obtain an efficient nCPAP therapy on Excessive Daytime Sleepiness (EDS) (group A)
•- Patients with OSA, complaining of Excessive Daytime Sleepiness but refusing to be treated by nCPAP therapy (group B)
•- Epworth score = 11
•- Patients having signed the informed consent form
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA (ICSD 2005): Patient with narcolepsy - sleep debt not due to OSA (according to the physician‘s judgment) – non respiratory sleep fragmentation (Periodic legs movement…)
•- Patient suffering from a psychiatric disease
•- Severe comorbid medical or biological conditions that may jeopardize study participation at the discretion of the investigator
•- Positive beta HCG pregnant test or breast-feeding women
•- Women with child-bearing potential and no efficient birth-control method
•- Patient unable to understand and comply with the study protocol
•-Positive serology testes – HCV – HBsAg and HIV (optional)

发起方