E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obstructive sleep apnea (OSA) is a prevalent disorder and characterised by sleepiness during the daytime, fatigue and impairments of concentration. OSA can also lead to cardiovascular pathology due to an increase of sympathetic activity and possibly also by complex inflammatory processes and oxidative stress at the vascular wall due to intermittent hypoxemia. It is particularly important to modulate and describe the structure of the vascular wall in this population. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary aim of this study is: to describe, in a sensitive and adequate manner, the structural and functional changes (FMD, IMT, echocardiography) of the vascular wall over a period of 48 weeks. |
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E.2.2 | Secondary objectives of the trial |
The second aim is: to describe chronological changes in lipid concentrations and oxidative stress markers and to describe resistance changes based on computational fluid dynamics (CFD) before and after adequate treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. male or female >25 years 2. OSA patients with AHI>20 3. Eligible for CPAP therapy according to the Belgian OSA convention
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E.4 | Principal exclusion criteria |
1. patients who cannot delay CPAP therapy 2. excessive disturbing sleepiness in opinion of the doctor who advises immediate treatment 3. pregnancy/lactation or becoming pregnant during the study period 4. common cold the last 2W before the start of the study 5. significant GI, liver, cardiovascular, neurological, renal or hematologic disease, uncontrolled with the current treatment 6. use of ICS, nasal and oral corticosteroids, NAC, statins, antibiotic use 8 weeks before the start of the study 7. patients with dislipidemia (totaal CH > 240 mg/dl, LDL > 160, HDL<35, TG>200) 8. use of vitamines 9. coronary artery disease 10. diabetes mellitus 11. COPD, asthma, lung cancer, TB, bronchiectasia 12. atrial fibrillation 13. allergy to contrast fluid 14. smokers 15. patients who recently had a CT-scan or angiographic examination 16. patients who are participating in another study Note: Patients who use one of the following medications can not participate in the study: Ciclosporine, warfarine, fibrates, cholesterol lowering medications, medication against indigestion, antibiotics, anticonceptive medication of hormon substitution therapy.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary aim of this study is to describe, in a sensitive and adequate manner, the structural and functional changes (FMD, IMT, echocardiography) of the vascular wall over a period of 48 weeks. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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When 40 sujects are included en have completed the whole study duration, this means 1 year after inclusion of the last included patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |