New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
|ClinicalTrials.gov Identifier: NCT01525160|
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : April 10, 2014
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.
|Condition or disease|
|Obstructive Sleep Apnoea Hypopnoea Syndrome Biomarkers of Fibrin Clot Structure Biomarkers of Vascular Endothelial Injury|
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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||66 participants|
|Observational Model:||Case Control|
|Official Title:||Novel Biomarkers for Haemostasis in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||March 2013|
- Difference between fractal dimension (Df) in patients with OSAHS and controls [ Time Frame: 18 months ]
- Difference in Df before and after a night's sleep in OSAHS and controls. [ Time Frame: 18 months ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525160
|Prince Philip Hospital|
|Llanelli, Dafan, United Kingdom, SA14 8QF|
|Principal Investigator:||Kier Lewis, MD MBChB||Prince Philip Hospital|
|Study Director:||Phillip A Evans, Prof||Morriston Hospital|