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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United Kingdom
  • Dafan
    • Llanelli, Dafan, United Kingdom, SA14 8QF
      • Prince Philip Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between fractal dimension (Df) in patients with OSAHS and controls	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in Df before and after a night's sleep in OSAHS and controls.	18 months

Collaborators and Investigators

• Sponsor: Hywel Dda Health Board
• Collaborators: Swansea University; National Institute for Health Research, United Kingdom; Abertawe Bro Morgannwg University NHS Trust
• Investigators: Principal Investigator: Kier Lewis, MD MBChB, Prince Philip Hospital; Study Director: Phillip A Evans, Prof, Morriston Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: C-reactive protein; Fractal dimension; Haemostasis; Clot structure; Gel point; serum amyloid A; vascular cell adhesion molecule-1; intercellular adhesion molecule-1
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: RES-54