Novel Biomarkers for Haemostasis in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Difference between fractal dimension (Df) in patients with OSAHS and controls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 year old with h/o daytime sleepiness, snoring and apnoeas
排除标准
- •Refusal to give written informed consent.
- •Personal or family history of pro- thrombotic or bleeding disorders, severe liver disease (clotting problems) and those prescribed warfarin or heparin.
- •Those with borderline sleep studies (4% Diprate or AHI 10-14 per hour).
- •Aged less than 18 years or greater than 80 years.
结局指标
主要结局
Difference between fractal dimension (Df) in patients with OSAHS and controls
时间窗: 18 months
次要结局
- Difference in Df before and after a night's sleep in OSAHS and controls.(18 months)
研究者
Dr Maria Wilczynska
Clinical Research Fellow in Respiratory Medicine
Hywel Dda Health Board