Obstructive Sleep Apnoea Hypopnoea Syndrome Clinical Trial
Official title:
Novel Biomarkers for Haemostasis in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
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.
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:
1. 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.
2. To test the null hypothesis that there is no significant difference in measured markers
following 1 month of CPAP treatment, in those with OSAHS.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00358800 -
REMStar Auto With C-Flex – In-Laboratory Performance v. Conventionally Titrated CPAP Therapy: Performances and Preferences
|
N/A |