New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
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Purpose
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 |
|---|
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Obstructive Sleep Apnoea Hypopnoea Syndrome Biomarkers of Fibrin Clot Structure Biomarkers of Vascular Endothelial Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Novel Biomarkers for Haemostasis in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome |
- Difference between fractal dimension (Df) in patients with OSAHS and controls [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Difference in Df before and after a night's sleep in OSAHS and controls. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Frozen aliquots of citrated plasma
| Enrollment: | 66 |
| Study Start Date: | October 2011 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Subjects are recruited prospectively from a specialist sleep-disordered breathing clinic in Prince Philip Hospital, Hywel Dda Health Board. They are referred from both primary and secondary care with varying degrees of symptoms suggestive of OSAHS (daytime sleepiness, snoring and/or nocturnal apneas).
Inclusion Criteria:
- 18-80 year old with h/o daytime sleepiness, snoring and apnoeas
Exclusion Criteria:
- 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.
Contacts and Locations| United Kingdom | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dr Maria Wilczynska, Clinical Research Fellow in Respiratory Medicine, Swansea University |
| ClinicalTrials.gov Identifier: | NCT01525160 History of Changes |
| Other Study ID Numbers: | RES-54 |
| Study First Received: | January 31, 2012 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United Kingdom:Dyfed Powys Research Ethics Comittee United Kingdom: Research and Development Department |
Keywords provided by Abertawe Bro Morgannwg University NHS Trust:
|
Clot structure Haemostasis Gel point Fractal dimension |
serum amyloid A C-reactive protein vascular cell adhesion molecule-1 intercellular adhesion molecule-1 |
Additional relevant MeSH terms:
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Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013