The study aims to confirm the effectiveness and safety of BF2.649 by comparing it with a placebo (a pharmacologically inactive product) for the treatment of excessive daytime sleepiness associated with Obstructive Sleep Apnoea treated by nCPAP.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 280

Inclusion Criteria

-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

Exclusion Criteria

- 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 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 (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
- 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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