Obstructive Sleep ApneaOSAVTENCT01051297
Obstructive Sleep Apnea and Venous Thromboembolism
An observational study of Obstructive Sleep Apnea and Venous Thrombosis, run by University of Missouri-Columbia.
Trial summary
There is a clear link between obstructive sleep apnea (OSA) and cardiovascular disease. However, there has been no clear link between OSA and venous thromboembolism (VTE). The objective of this study is to evaluate such a link. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Venous Thrombosis, Pulmonary Embolism
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to May 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (>=18 years) with sleep study , OSA or VTE
Who may be able to join
- Adult patients (>= 18 years) with sleep study, OSA or VTE
Who cannot join
- Below 18 years of age
About this study
Official title: Patients With Obstructive Sleep Apnea (OSA), Independent of Obesity, Are at Increased Risk of Venous Thromboembolic Events (VTE)
There is a clear link between obstructive sleep apnea (OSA) and cardiovascular disease. However, there has been no clear link between OSA and venous thromboembolism (VTE). The objective of this study is to evaluate such a link.
Read the detailed description
Design:
- retrospective chart review of all patients with VTE over 10 year period
- retrospective chart review of all patients with OSA over 10 year period
- prospective 1 year follow up of all patients diagnosed with new VTE
- prospective 1 year follow up of all patients undergoing sleep study
- Keywords
- Obstructive sleep apnea, venous thrombosis, pulmonary embolism, venous thromboembolism
- Medical subject headings
- Sleep Apnea, Obstructive, Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VTE -PROSPECTIVE | Patients diagnosed with VTE | |
| sleep study group -PROSPECTIVE | patients undergoing sleep study | |
| VTE-Retrospective | patients with VTE , chart review | |
| OSA-retrospective | PATIENT WITH OSA -CHART REVIEW | |
| OSA group -PROSPECTIVE | patients diagnosed with OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of VTE for the OSA cohort
Measured: 12 months
incidence of OSA for the VTE cohort
Measured: 12 months
Secondary outcomes (3)
death
Measured: 12 month
bleeding
Measured: 12 months
composite outcome of death, VTE , or bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- OUSAMA DABBAGH, MD, Principal investigator, University of Missouri-ColumbiaJAMES P BOSANQUET, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051297
- Sponsor's protocol ID
- 1132357
- Acronym
- OSAVTE
- Status last verified
- Sep 2016
- First submitted
- 15 Jan 2010
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bosanquet JP, Bade BC, Zia MF, Karo A, Hassan O, Hess BT, Dabbagh O. Patients with venous thromboembolism appear to have higher prevalence of obstructive sleep apnea than the general population. Clin Appl Thromb Hemost. 2011 Nov-Dec;17(6):E119-24. doi: 10.1177/1076029610389023. Epub 2010 Dec 15.
PubMed 21159707
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Obstructive Sleep Apnea (OSA), Independent of Obesity, Are at Increased Risk of Venous Thromboembolic Events (VTE)
- ClinicalTrials.gov ID
- NCT01051297
- Acronym / sponsor ID
- OSAVTE / 1132357
- Keywords
- Obstructive sleep apnea, venous thrombosis, pulmonary embolism, venous thromboembolism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left the institution
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Jan 2010 (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.
There is a clear link between obstructive sleep apnea (OSA) and cardiovascular disease. However, there has been no clear link between OSA and venous thromboembolism (VTE). The objective of this study is to evaluate such a link.
Detailed description
Design:
- retrospective chart review of all patients with VTE over 10 year period
- retrospective chart review of all patients with OSA over 10 year period
- prospective 1 year follow up of all patients diagnosed with new VTE
- prospective 1 year follow up of all patients undergoing sleep study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VTE -PROSPECTIVE | – | –Patients diagnosed with VTE |
| sleep study group -PROSPECTIVE | – | –patients undergoing sleep study |
| VTE-Retrospective | – | –patients with VTE , chart review |
| OSA-retrospective | – | –PATIENT WITH OSA -CHART REVIEW |
| OSA group -PROSPECTIVE | – | –patients diagnosed with OSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>=18 years) with sleep study , OSA or VTE
Key inclusion criteria (1 listed)
- Adult patients (>= 18 years) with sleep study, OSA or VTE
Key exclusion criteria (1 listed)
- Below 18 years of age
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
incidence of VTE for the OSA cohort
Time frame: 12 months
incidence of OSA for the VTE cohort
Time frame: 12 months
3 secondary outcomes
death
Time frame: 12 month
bleeding
Time frame: 12 months
composite outcome of death, VTE , or bleeding
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Derived from this study: PubMed 21159707Bosanquet JP, Bade BC, Zia MF, Karo A, Hassan O, Hess BT, Dabbagh O. Patients with venous thromboembolism appear to have higher prevalence of obstructive sleep apnea than the general population. Clin Appl Thromb Hemost. 2011 Nov-Dec;17(6):E119-24. doi: 10.1177/1076029610389023. Epub 2010 Dec 15.
- Individual participant dataSharing planned: No
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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.
OUSAMA DABBAGH, MD principal investigator
University of Missouri-Columbia
JAMES P BOSANQUET, MD principal investigator
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Venous Thrombosis, run by University of Missouri-Columbia.
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 1 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: stopped early, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Investigator left the institution). Results are not available in the source record.
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?
incidence of VTE for the OSA cohort (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01051297, which also lists 1 linked publication.
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 30 Sep 2016.