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

Obstructive Sleep Apnoea Hypopnoea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525160
• Other study ID #: RES-54
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: April 8, 2014
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: Hywel Dda Health Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom:Dyfed Powys Research Ethics ComitteeUnited Kingdom: Research and Development Department
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Biomarkers of Fibrin Clot Structure
• Biomarkers of Vascular Endothelial Injury
• Obstructive Sleep Apnoea Hypopnoea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Locations

Country	Name	City	State
United Kingdom	Prince Philip Hospital	Llanelli	Dafan

Sponsors (4)

Lead Sponsor	Collaborator
Hywel Dda Health Board	Abertawe Bro Morgannwg University NHS Trust, National Institute for Health Research, United Kingdom, Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between fractal dimension (Df) in patients with OSAHS and controls		18 months	No
Secondary	Difference in Df before and after a night's sleep in OSAHS and controls.		18 months	No