The study aims to confirm the effectiveness and safety of BF2.649 over placebo for the treatment of excessive daytime sleepiness associated with Obstructive Sleep Apnoea syndrome in patients who refuse CPAP therapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 280

Inclusion Criteria

-Male and/or female outpatients aged from at least 18 years of age
-Polysomnography
-Patients refusing to be treated by nCPAP therapy, and still complaining of Excessive Daytime Sleepiness
-Epworth Sleepiness scale = 12
-Beck Depression Inventory 13 items (BDI-13 items): score < 16 and item G = 0
-Mini Mental State Examination (MMSE) ? 28
-Body Mass Index (BMI) ? 40 Kg/m2
-Female patients with child-bearing potential using a medically accepted method of birth control
-If specified by the investigator, the patient must be willing not to operate a car (if sleepy at wheel) or heavy machinery for the duration of the trial, or as long as the investigator deems it clinically indicated. In addition, patients should be willing to maintain during the study their usual behaviours which could affect their diurnal sleepiness (e.g. circadian rhythm, caffeine consumption, nocturnal sleep duration).
-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

Exclusion Criteria

•Patients suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders (ICSD 2005) without OSA
•Patients with co-existing narcolepsy (ICSD 2005)
•Patients with sleep debt not due to OSA
•Patients with non-respiratory sleep fragmentation
•Shift work - professional drivers
•Refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risk for the patient to stop the therapy
•Patients suffering from a psychiatric disease already known or diagnosed during the trial. The necessary examinations have to be carried out at each visit.
•Acute or chronic disease preventing the improvement assessment
•Current or recent (within one year) history of drug, alcohol, narcotic or other substance abuse or dependence.
•Any significant serious abnormality of the cardiovascular system
•Severe comorbid medical and biological conditions that may jeopardize study participation at the discretion of the investigator.
•Positive serological test (optional HIV, HCV and HBsAg)
•Pregnant or breast-feeding women
•Women with child-bearing potential and no efficient birth-control method
•Patients unable to understand the study protocol
•Patients with suspected or known hypersensitivity to study medication
•Patients with a dominant arm deficiency impeding the achievement of the tests
•Patients using a prohibited medication
•Congenital galactose poisoning, glucose and galactose malabsorption, deficit in lactase
•Patients participating in another study or being in a follow–up period for another study
?Persons that have been placed in an institution due to official or judicial order.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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