Study of the vascular wall with functional imaging in OSA patients.

• Conditions: 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.

• Registration Number: EUCTR2010-020698-17-BE
• Lead Sponsor: Antwerp University Hospital : Department Respiratory Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-07
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of this study is:<br>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:<br>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.