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.
Conditions
Interventions
Trade Name: Lipitor 40 mg tablets
Product Name: Lipitor
Product Code: C10AA05
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Antwerp University Hospital : Department Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, HDL200) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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.;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. | — |
Countries
Belgium
Outcome results
None listed