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

This study has been completed.
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Abertawe Bro Morgannwg University NHS Trust
Swansea University
Information provided by (Responsible Party):
Dr Maria Wilczynska, Hywel Dda Health Board
ClinicalTrials.gov Identifier:
NCT01525160
First received: January 31, 2012
Last updated: April 8, 2014
Last verified: April 2014

January 31, 2012
April 8, 2014
October 2011
September 2012   (final data collection date for primary outcome measure)
Difference between fractal dimension (Df) in patients with OSAHS and controls [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01525160 on ClinicalTrials.gov Archive Site
Difference in Df before and after a night's sleep in OSAHS and controls. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Frozen aliquots of citrated plasma

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).

  • Obstructive Sleep Apnoea Hypopnoea Syndrome
  • Biomarkers of Fibrin Clot Structure
  • Biomarkers of Vascular Endothelial Injury
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
March 2013
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01525160
RES-54
No
Dr Maria Wilczynska, Hywel Dda Health Board
Hywel Dda Health Board
  • National Institute for Health Research, United Kingdom
  • Abertawe Bro Morgannwg University NHS Trust
  • Swansea University
Principal Investigator: Kier Lewis, MD MBChB Prince Philip Hospital
Study Director: Phillip A Evans, Prof Morriston Hospital
Hywel Dda Health Board
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP