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
  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
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

Resource links provided by NLM:


Further study details as provided by Hywel Dda Health Board:

Primary Outcome Measures:
  • Difference between fractal dimension (Df) in patients with OSAHS and controls [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525160

Locations
United Kingdom
Prince Philip Hospital
Llanelli, Dafan, United Kingdom, SA14 8QF
Sponsors and Collaborators
Hywel Dda Health Board
National Institute for Health Research, United Kingdom
Abertawe Bro Morgannwg University NHS Trust
Swansea University
Investigators
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, Hywel Dda Health Board
ClinicalTrials.gov Identifier: NCT01525160     History of Changes
Other Study ID Numbers: RES-54
Study First Received: January 31, 2012
Last Updated: April 8, 2014
Health Authority: United Kingdom:Dyfed Powys Research Ethics Comittee
United Kingdom: Research and Development Department

Keywords provided by Hywel Dda Health Board:
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:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Wounds and Injuries
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 July 20, 2014