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

NCT01525160 | Completed

• 1 other identifier: RES-54
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Clot structure; Haemostasis; Gel point; Fractal dimension; serum amyloid A; C-reactive protein; vascular cell adhesion molecule-1; intercellular adhesion molecule-1

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (1)

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

  18 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• year old with h/o daytime sleepiness, snoring and apnoeas

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hywel Dda Health Board: lead
• National Institute for Health Research, United Kingdom: collaborator
• Abertawe Bro Morgannwg University NHS Trust: collaborator
• Swansea University: collaborator

Study Sites (1)

Prince Philip Hospital

Llanelli, Dafan, SA14 8QF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen aliquots of citrated plasma

Study Officials

• Kier Lewis, MD MBChB

  Prince Philip Hospital

  PRINCIPAL INVESTIGATOR

• Phillip A Evans, Prof

  Morriston Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow in Respiratory Medicine

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 2, 2012
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2013
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

GB (1)