New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome

Completed

• Conditions: Obstructive Sleep Apnoea Hypopnoea Syndrome; Biomarkers of Fibrin Clot Structure; Biomarkers of Vascular Endothelial Injury

• Registration Number: NCT01525160
• Lead Sponsor: Hywel Dda Health Board

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 Description

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-02
• Primary Completion: 2012-09
• Study Completion: 2013-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between fractal dimension (Df) in patients with OSAHS and controls	18 months

Secondary Outcome Measures

Name	Time	Method
Difference in Df before and after a night's sleep in OSAHS and controls.	18 months

Trial Locations

Locations (1)

Prince Philip Hospital; 🇬🇧 Llanelli, Dafan, United Kingdom