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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50606

Enrollment

Registered

2017-01-05

Start date

2018-03-22

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea OSAS

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >50 years 2. AHI>30 or AHI

Exclusion criteria

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 (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)

Design outcomes

Primary

Measure	Time frame
The main study parameter is the measurement of arterial wall inflammation (target-to-background ratio).	—

Secondary

Measure	Time frame
* To assess the degree of splenic and bone-marrow metabolic activity as measured by 18F-FDG PET/CT in subjects with severe OSAS compared to matched controls with mild OSAS * To determine the quantity of intermediate monocytes in subjects with severe OSAS compared to matched controls with mild OSAS * To assess the results of pulse wave velocity (PWV) measurement using SphygmoCor and MAP, CO, SV, SVR and xBRS values measured with Nexfin® in subjects with severe OSAS compared to matched controls with mild OSAS and to assess these variables for potential correlations with 18F-FDG PET/CT data or data from other measurements * To assess the correlation between the 18F-FDG PET/CT measurements and circulating markers of inflammation * To assess the correlation between the (relative) quantity and phenotype of circulation blood monocytes * To assess the difference in priming of NETosis of isolated circulating neutrophils in subjects with severe OSAS compared to matched controls with mild OSAS and potential correlations with other outcomes * To assess the difference in epigenetic modifications in isolated monocytes and/or other cell types in subjects with severe OSAS compared to matched controls with mild OSAS and potential correlations with other outcomes	—

Measure

Time frame

* To assess the degree of splenic and bone-marrow metabolic activity as measured by 18F-FDG PET/CT in subjects with severe OSAS compared to matched controls with mild OSAS * To determine the quantity of *intermediate* monocytes in subjects with severe OSAS compared to matched controls with mild OSAS * To assess the results of pulse wave velocity (PWV) measurement using SphygmoCor and MAP, CO, SV, SVR and xBRS values measured with Nexfin® in subjects with severe OSAS compared to matched controls with mild OSAS and to assess these variables for potential correlations with 18F-FDG PET/CT data or data from other measurements * To assess the correlation between the 18F-FDG PET/CT measurements and circulating markers of inflammation * To assess the correlation between the (relative) quantity and phenotype of circulation blood monocytes * To assess the difference in priming of NETosis of isolated circulating neutrophils in subjects with severe OSAS compared to matched controls with mild OSAS and potential correlations with other outcomes * To assess the difference in epigenetic modifications in isolated monocytes and/or other cell types in subjects with severe OSAS compared to matched controls with mild OSAS and potential correlations with other outcomes

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Countries

Netherlands

Outcome results