Assessment of cardiovascular risk in patients with severe obstructive sleep apnea syndrome

Recruiting

• Conditions: Obstructive Sleep Apnea; OSAS; 10011082; 10046304; 10003216

• Registration Number: NL-OMON50606
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Age >50 years
2. AHI>30 or AHI <15 depending on group
3. Symptoms matching the diagnosis of OSAS for at least 6 months
4. OSAS as diagnosed by polysomnography

Exclusion Criteria

1. Malignant diseases or any clinically significant medical condition that
could interfere with the conduct of the study in the opinion of the
investigator.
2. Chronic or recent (<1 month) infections and/or clinical signs of acute
infection and/or CRP >10 mg/L
3. Auto-immune diseases
4. Recent or chronic immunosuppressant or antibiotic usage
5. Type I or II diabetes mellitus
6. Smoking or alcohol abuse
7. Sleeping disorder other than OSAS
8. Standard contra-indications to 18F-FDG PET, and CT based on physicians
experience and current practices
9. Exposure to radiation in a different study
10. History of MI/Stroke or known coronary artery diseas
11. BMI >40 kg/m2
12. Weight above 190kg, diameter >69cm (limits CT scanner)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the measurement of arterial wall inflammation<br /><br>(target-to-background ratio).</p><br>