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

• Conditions: Patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS); MedDRA version: 12.1Level: LLTClassification code 10015595Term: Excessive daytime sleepiness

• Registration Number: EUCTR2009-017248-14-FI
• Lead Sponsor: BIOPROJET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-29
• Last Update Posted: 2 June 2014

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 (compliance checked on the clock-time counter of the CPAP machine)
- MMS = 28 (an example of MMSE 11 questionnaire is provided in Appendix 9)
- BDI-13 items: score < 16 and item G (suicidal ideation) 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:
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

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), judged on clinical criteria
- Patient with sleep debt not due to OSA (according to physician?s judgment)
- Patient with non respiratory sleep fragmentation (restless legs syndrome…)
- 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, e.g. recent myocardial infarction, angina, hypertension or dysrhythmias (within the previous 6 months), Electrocardiogram Bazett?s corrected QT interval higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse.
- Severe co-morbid medical, or biological condition that may jeopardize the study participation, at the discretion of the investigator (particularly, in the cardiovascular system and instable diabetes)
- 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 (lactose in placebo)
- Patient participating in another study, or being in a follow-up period in another study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified