EUCTR2009-017248-14-DK进行中（未招募）1 期
BF2.649 in patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS). - HAROSA I
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BIOPROJET
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Male and/or female outpatients of at least 18 years of age
- •- 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.
- •- Polysomnography
- •- nCPAP = 4 hours / day
- •- MMS = 28
- •- BDI-13 items: score < 16 and item G (suicidal ideation) of BDI13 = 0
- •- BMI <= 40 kg/m²
- •- Epworth score = 12
- •- Female patients with child-bearing potential using a medically accepted method of birth control
- •- If specified by the investigator, patients must be willing not to operate a car or heavy machinery for the duration of the trial
- •- Patients having signed and dated the informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Patient suffering from chronic severe insomnia according to International Classification of Sleep Disorders (ICSD 2005) without OSA
- •- Patient with co-existing narcolepsy (ICSD 2005
- •- Patient with sleep debt not due to OSA
- •- Patient with non respiratory sleep fragmentation
- •- Shift work – Professional drivers
- •- Refusal from the patient to stop any current therapy for excessive daytime sleepiness, or predictable risks for the patient to stop the therapy
- •- Patient suffering from a psychiatric disease
- •- Acute or chronic disease preventing the improvement assessment (severe COPD)
- •- Current or recent (within one year) history of drugs, alcohol, narcotic, or other substance abuse or dependence
- •- Any significant serious abnormality of the cardiovascular system
- •- Severe co-morbid medical, or biological condition that may jeopardize the study participation, at the discretion of the investigator
- •- Positive serology tests ( HCV – HbsAg and optional HIV)
- •- Pregnant or breast-feeding women
- •- Women with child-bearing potential and no efficient birth-control method
- •- Patient unable to understand the study protocol
- •- Patient with suspected or known hypersensitivity to study medication
- •- Patient with a dominant arm deficiency impeding the achievement of the tests
- •- Patient using a prohibited treatments
- •- Congenital galactose poisoning, glucose and galactose malabsorption, deficit in lactase
- •- Patient participating in another study, or being in a follow-up period in another study
研究者
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