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Completed

NCT Number: NCT01525160

New Markers to Measure Clotting 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.

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Key information

Conditions

Obstructive Sleep Apnoea Hypopnoea Syndrome Biomarkers of Fibrin Clot Structure Biomarkers of Vascular Endothelial Injury

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince Philip Hospital

Llanelli, Dafan, SA14 8QF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Difference between fractal dimension (Df) in patients with OSAHS and controls

    Time frame: 18 months

Secondary outcomes

  1. Difference in Df before and after a night's sleep in OSAHS and controls.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Hywel Dda Health Board

Other

Collaborators

  • Abertawe Bro Morgannwg University NHS Trust
  • National Institute for Health Research, United Kingdom
  • Swansea University

Registry information

Official study title

Novel Biomarkers for Haemostasis in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 2, 2012
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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