Obstructive Sleep Apnoea Hypopnoea SyndromeNCT01525160
New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
An observational study of Obstructive Sleep Apnoea Hypopnoea Syndrome and Biomarkers of Fibrin Clot Structure, run by Hywel Dda Health Board at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnoea Hypopnoea Syndrome, Biomarkers of Fibrin Clot Structure, Biomarkers of Vascular Endothelial Injury
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 18-80 year old with h/o daytime sleepiness, snoring and apnoeas
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
Read the 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:
- 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.
- To test the null hypothesis that there is no significant difference in measured markers following 1 month of CPAP treatment, in those with OSAHS.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between fractal dimension (Df) in patients with OSAHS and controls
Measured: 18 months
Secondary outcomes (1)
Difference in Df before and after a night's sleep in OSAHS and controls.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnoea Hypopnoea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hywel Dda Health Board
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Abertawe Bro Morgannwg University NHS Trust, Swansea University
- Responsible party
- Principal investigator, Dr Maria Wilczynska, Hywel Dda Health Board
- Investigators
- Kier Lewis, MD MBChB, Principal investigator, Prince Philip HospitalPhillip A Evans, Prof, Study director, Morriston Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525160
- Sponsor's protocol ID
- RES-54
- Status last verified
- Apr 2014
- First submitted
- 31 Jan 2012
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers for Haemostasis in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
- ClinicalTrials.gov ID
- NCT01525160
- Acronym / sponsor ID
- RES-54
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hywel Dda Health BoardUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Abertawe Bro Morgannwg University NHS Trust, Swansea University
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 18-80 year old with h/o daytime sleepiness, snoring and apnoeas
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between fractal dimension (Df) in patients with OSAHS and controls
Time frame: 18 months
1 secondary outcome
Difference in Df before and after a night's sleep in OSAHS and controls.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kier Lewis, MD MBChB principal investigator
Prince Philip Hospital
Phillip A Evans, Prof study director
Morriston Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnoea Hypopnoea Syndrome and Biomarkers of Fibrin Clot Structure, run by Hywel Dda Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between fractal dimension (Df) in patients with OSAHS and controls (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.