Clinical Trial: New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Novel Biomarkers for Haemostasis in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
Brief Summary:
Obstructive Sleep Apnoea Hypopnoea Syndrome(OSAHS)affects at least 4% of males and 2% of females.
OSAHS is the combination of excessive daytime sleepiness, snoring and apnoeas (stopping breathing at night). As well as affecting tiredness, mood, concentration and quality of life - there is growing concern that it can increase the risk of high blood pressure, heart problems, strokes and thromboses (clots in the veins).
It appears that OSAHS may affect the thickness of the blood and cause it to clot more easily it also causes damage to the lining of the blood vessels (endothelial injury). These effects seem independent of other risk factors such as obesity, smoking, family history of clots etc.
The investigators are testing new biomarkers: gel point and fractal dimension developed at the Swansea University to measure the 'clotting' of the blood in people with OSAHS and a similar group of people who snore and who are sleepy but do not have OSAHS on sleep studies (Controls) Also markers of vascular inflammation are being measured.
Detailed Summary:
Primary objective:
The primary outcome of this study is to test the null hypothesis that no significant difference exists between fractal dimension (Df)and vascular injury markers including serum amyloid A (SAA), C-reactive protein (CRP), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1)in patients with OSAHS and sleepy, snoring controls of similar age, gender and BMI.
Secondary objectives:
- To test the null hypothesis that there is no significant difference in measured markers before and after a night's sleep in OSAHS and controls.
- To test the null hypothesis that there is no significant difference in measured markers following 1 month of CPAP treatment, in those with OSAHS.
Sponsor: Hywel Dda Health Board
Current Primary Outcome: Difference between fractal dimension (Df) in patients with OSAHS and controls [ Time Frame: 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Difference in Df before and after a night's sleep in OSAHS and controls. [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: Hywel Dda Health Board
Dates:
Date Received: January 31, 2012
Date Started: October 2011
Date Completion:
Last Updated: April 8, 2014
Last Verified: April 2014
